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(generated from captions) ? Theme music MAN: It won't be a small incision... It's an operation that can KERRY O'BRIEN: dramatically improve your life. one operation in your life, I always say if you're gonna have it should be a hip replacement. it's become a disaster. But, for many, looked like a sewer pipe. The bone, he said, I started feeling nausea. I had lots of fainting spells, That patient is seriously toxic. that's now being described A new type of hip replacement

in the history of orthopaedics. as perhaps the biggest disaster Welcome to Four Corners. In this age of mass manufacturing, of cars being recalled we've grown used to stories to replace a faulty part. there's a moment of inconvenience If it happens to be yours, and you get your car back. when it's your body It's a different proposition under the knife. and you may have to go back Far worse still when the recall comes poisoned by the faulty part only after your body has been and you're suffering intense pain. the damage cannot be repaired. Or, worse again, of hip replacement with a relatively new type That is what has happened using metal-on-metal technology, from cobalt and chromium - made partly and patients as a big leap forward sold originally to doctors in joint replacement. 93,000 people worldwide By last year,

to implant this type of device. had had hip replacement surgery 5,500 of them were in Australia. that their device is suspect, Most have now been alerted the hard way but many had already found out that something was badly wrong. and the medical profession should the manufacturer The question is - when the alarm bells began to ring? have responded quicker in Australia And should the government regulator cobalt and chromium devices have given the green light to these without any clinical trials? will now be dealt with in court Those questions and possibly in the Parliament. who trusted their doctor's advice For hundreds of Australians this has now become a horror story. by Quentin McDermott. Investigated for Four Corners Ah, looks wonderful! when I got back. I expected to see a jungle and six months in hospital, After five operations QUENTIN MCDERMOTT: in Adelaide Ron Barnes is finally back home with his devoted wife, Yensie. hardly recognise the place. God, it's good to be home - It's flaming nice to have you home. Hard to recognise it. But all is not well with Ron. in front of the other is an ordeal. Just putting one foot

I'll just open the door first, love. One leg... two legs. Come on, legs, don't let me down. very well, so you'll have to... I'm sorry, I didn't park the car And now that he's missing one hip, to his front door walking up the two small steps is like climbing Everest. On three - one, two, three, up! Lovely. And we'll do it again. Ooh. Yep. One leg up to heaven. One, two, three. My hip's playing up. Ready? and then we'll sit down. A little bit more, love, You right? Yep. Yep. (Sighs) Oh! Oh, home! (Laughs) Home at last! My goodness, it feels good.

led an extremely active life. Once upon a time, Ron Barnes during World War II. I was 16 when I went to sea Yeah, in the Merchant Navy. as a Master Mariner. And I finished up many years later out here in Australia. I retired as Captain, at Elizabeth - Comedy Capers. I produced the Boy Scout Gang Show Ah, that was for 37 years. we'd go around to RSL clubs, About 25 of us, senior clubs and so forth, with songs and entertain the over-50s make them cry, we'd make them sing. and we'd make them laugh, we'd and all sorts of things. We used to dance, take the dogs for walks. We used to walk all the time, On holidays we'd trek for hours. the kids' inheritance We'd been spending I think we've had about 14 cruises. by going on -

This is what's killed me. This has. I'll get you down these steps. OK, darl, Buddy's out, so now Ron Barnes had in 2005 'This' is the total hip replacement with a new kind of metal prosthesis. It was meant to make him more mobile. I had this one, the right hip, done something went pear-shaped in there. and about six months later and they operated again. I never did find out what, After that on my hip. I got these bursae coming up grew worse and worse. The bursa, or inflammation, It ached. it ached all the time. That's how he put it - And it did no good at all either, to the line of a pair of trousers a grapefruit on the side of his leg. with a great big bursa the size of her own orthopaedic surgeon, When Yensie Barnes went to see at the growth on her husband's hip. she asked him to take a look And he said, 'Oh my God.' and have a look see.' He said, 'Let's drain it of metal in here!' In the tray. He said, 'Look, there's pieces And what it meant had been disintegrating was that the whole hip

in my... in my hip here floating around inside the bursa. and pieces of metal were all He said, 'That's got to come out.' the metal joint was removed, In an operation like this one, a gruesome business. but it proved to be A lot of the flesh had turned black, a lot more flesh and more muscle and he had to cut away normal circumstances. than they would under didn't end there. Ron Barnes's horror story to deal with a serious infection, Four more operations were needed culminating in the decision to remove his hip altogether. little to cheer about. His surgeon gave him of acute pain, He said you could have six months three years of adjustment. off this leg. I've lost about two to three inches it's like walking on sponge, rubber. When I walk without a shoe on, backwards and forward, While I can move the leg trying to move it sideways. I have major problems it just flops around like that. I pick my leg up -

DePuy Orthopaedics, part of the huge Johnson & Johnson health-care empire provided the replacement hip that caused Ron Barnes so much grief. (Dramatic music)

This promotional film advertises the range of devices marketed by DePuy as replacement bones and joints, including hips. The implant Ron Barnes received was known as an ASR, or Articular Surface Replacement, and was part of a wider group of prostheses known as 'metal-on-metal'. Its components are made from cobalt, chromium and titanium. Two versions were marketed by DePuy, one involving a total hip replacement, the other designed to resurface the hip without replacing it totally. By definition, a resurfacing is exactly what it sounds like, it resurfaces the head, it resurfaces the socket.

Functionally, patients get better, quicker. And they're back to normal activity within about six weeks, whereas as with a total hip replacement it often takes up to three months. Roger Oakeshott, an orthopaedic surgeon from Adelaide, is one of six surgeon designers from around the world who helped develop the ASR hip, and were rewarded with royalties. Here, Dr Oakeshott demonstrates the finer points of resurfacing for the benefit of doctors and surgeons attending a conference. What kind of cement do you use, Roger? This is SmartSet with Gentamicin. Between 2003 and 2010 surgeons implanted the DePuy ASR in 93,000 patients around the world,

5,500 of whom were Australians. The implant was approved for use in Australia by the Therapeutic Goods Administration, or TGA, which regulates medical devices. But the TGA relied on overseas expertise in making its decision. The DePuy hip prosthesis went through the usual assessment process and was approved on the basis of European certification by the British Standards Institute. It was thought at the time to have advantages over other hip prostheses because it required a smaller surgical incision, so it was thought to be better for patients, was the reason it was originally marketed. Resurfacing the hip rather than replacing it totally is heavily promoted to younger patients as a means of giving them greater, lasting mobility. But in 2006, when Roger Oakeshott carried out this operation, concerns about DePuy's resurfacing device were already being raised by the organisation that monitors artificial joints, the National Joint Replacement Registry. ..this is an orthopaedic tap.

The problem was the amount of corrective surgery, or revisions, having to be done to deal with implants that had failed. We were a little bit surprised about the number of revisions occurring. So we did actually, sort of, wave a flag and said, you know, there may be an issue with the ASR. So we mentioned that in 2006. And that was specifically with the resurfacing device. Could we have just a little more irrigation, please? 12 months later, alarm bells started to ring. The situation changed the following year when the ASR resurfacing certainly did become statistically significant from other resurfacing devices. And the company did respond on that occasion, and it released a warning about the device in 2007, to surgeons.

DePuy's safety alert, however, suggested that surgeons were at fault for not implanting the ASR correctly, and that... ..were to blame. There was no admission by DePuy that the device itself might be failing. But the following year, the National Joint Replacement Registry went even further, reporting a problem with the total hip replacement version of the ASR. In 2008 we also identified the ASR conventional hip as being an issue, in that it had also twice the risk of revision - at least twice the risk of revision compared to other conventional hip replacements.

Despite these repeated warnings that the risk of failure from the ASR hips was high, DePuy kept marketing them, and surgeons continued to use the devices in their patients. Bob Lugton had his total hip replacement in Brisbane in January 2008. Last year when he had become ill, he asked his GP to test his blood for cobalt and chromium, believing that metal ions had been worn away from the joint and entered his blood. When the result of that came back, showing that I had 750% higher cobalt levels than you should have, I rang my surgeon again and he suggested then I have a CT scan and a nuclear bone scan.

You can see here, that darker section there, that's where the cobalt's eaten away, has started to eat away my hip and these sections down here have been eaten away. How serious was this? These X-rays showed the damage done to his thigh bone by cobalt leeching from his joint. And shortly afterwards Bob Lugton had surgery to remove his ASR hip.

But what the X-rays didn't show was the full extent of the damage caused by the metal to the tissue surrounding the joint, which the surgeon only found when he was operating. When he opened me up he found that, ah, my flesh had turned a grey black around the hip area. The bone, he said, looked like a sewer pipe and was full of sludgy, grey material, and that was the same in my hip area where the acetabular cup was. That had to be ground out, out of that. and cleaned all the sludge So, the shadows here... symptoms There were other, less visible were also caused by cobalt poisoning. which Bob Lugton believes from this actual implant? What other symptoms did you get with my sight, troubles focusing, I had a lot of problems which still remains, I had terrible tinnitus, I had heart palpitations. Thank you. Here we go. similar symptoms to Bob Lugton's Catherine Sullivan experienced her right hip resurfaced. after she had I had, plus more. Every single one of those symptoms She takes a range of medication, to manage the pain. including morphine, OK, go again. One, two... Three. No, can't do it. One, two, three. Oh! God. How do people ever get used to doing this? Don't know. Roger Oakeshott performed Catherine Sullivan's hip replacement

at this clinic, in Adelaide in November 2008, two years after concerns were first raised about the resurfacing version of the DePuy ASR hip. Catherine was 43 years old. He suggested that they had this new product available called hip resurfacing, and it was a metal-on-metal product. be the way to go. We thought that would for younger people to do. It was designed Catherine Sullivan says But, after the operation, she began to feel more and more ill. I started feeling nausea. I had lots of fainting spells, sort of went good and bad, My eyesight I had tinnitus. I started having seizures.

completely unwell all the time. Just this feeling of being Over the next two years 20 to 30 doctors she estimates she visited and underwent a battery of tests what was wrong with her. to try and discover and CTs and MRIs I had X-rays and blood tests and ECGs and cardiograms that they do for your brain, and all of these scans all of these scans they do for your heart, things that they can look at for your liver and kidneys. It was ongoing. It became a nightmare. Finally, after hearing about Bob Lugton and his experience, Catherine Sullivan asked her doctor to arrange a blood test for cobalt and chromium. The cobalt came back at 1,042 nanomoles per litre and the chromium came back at 400 and something - nanomoles per litre. low 400s, I think - laboratory This note, from a leading pathology are normally 0-20 nanomoles per litre says that cobalt levels

85 nanomoles per litre and that levels greater than indicate toxicity. Catherine Sullivan's reading was as it should have been - 50 times as high a dangerously high level. Her cobalt level was so high for further analysis, that more blood was sent away level had climbed even higher - but that test showed her cobalt to 1,239 nanomoles per litre. was poisoning her system. The metal from her joint it was very serious. The doctor certainly thought straight away. It needed to be dealt with travelled to Melbourne Catherine Sullivan to have her prosthesis removed. Her surgeon there recorded the damage done

by the cobalt leeching from her implant. He wrote - It was one more patient for whom DePuy's device had failed. Historically, hip replacements are among the Western world's most popular and successful operations. It's a fantastic operation - hip replacement.

I always say if you're going to have one operation in your life it should be a hip replacement and it works well because it transforms you long-term success. and it's got great like Ross Crawford, But some orthopaedic surgeons, are becoming increasingly concerned to patients by metal-on-metal hips. about the potential risk posed Professor Crawford knows the damage to surrounding tissue that can be caused like the DePuy ASR, by metal prostheses when the implants fail badly. local concentrations You get very high of both metal ions, and, at times, through the tissue you can see the metal deposited particles in the local tissue. as just a black sheet of metal resurfacing operations Ross Crawford will not carry out metal-on-metal prosthesis. which require a metal-on-metal at all, And he won't use believing it isn't worth the risk. I never adopted it, but I'm very risk averse. Other surgeons still think it's worth the risk. They still think that it's a... ..that the benefits outweigh the potential downsides, and that's really very much a clinical judgement that each of us as individual surgeons has to make. Ross Crawford is now testing a controversial theory with hips that fail that cobalt toxicity in patients to localised tissue damage may not be limited in other serious ways. but may affect patients' health who've had hip replacements The people I speak to now that have come to revision, they've all had some symptoms in retrospect, with the cobalt poisoning. that I think are consistent hips have failed. But they are patients whose

a small number of patients So, whether we're just seeing who have problems and they're the ones who've come, of something, or whether we're at the tip is hard to predict. the tip of an iceberg? It could be. So it could be Ah, well, thank you. Hi, Eileen, how are you going? That's good... evidence of this. Ross Crawford has first-hand So we're about a few weeks after your revision. We are. And how's it all going? My mobility has finally eased, it's coming a little better as from yesterday. I still need the help of a crutch but not two anymore. The pain at night is still horrendous. During the day it's not so bad. Last July, Eileen Webber's life changed dramatically, right hip replaced with a DePuy ASR. four years after she had her who removed it in March this year. Ross Crawford was the surgeon I had the hip put in, 2006. It was fine. My health was great. everything, you know. We were going on holidays, elderly lady. I was a very, very active Lots of volunteer work, and stuff. And then - July 2010 -

I had a stroke, because I'm not stroke material. and couldn't understand why, health was steadily deteriorating. She kept a journal of how her no evidence or obvious reasons why. 'My stroke, the 21st July - Spoke to my son, John, in Singapore,

as soon as possible and John urged me to act of debris in my bloodstream. because of the possibility Feeling constantly tired.' marked systemic complications, She was suffering from quite which are complications away from the hip joint. Her symptoms fit perfectly with cobalt toxicity. Last year, Eileen Webber suffered a mild stroke. Yes. Was that caused by her hip implant? The answer is we don't know. It's... We just have to put it in context. She had all these neurological problems. She had cobalt levels in her blood, of 20 times normal. It is consistent with the cobalt, that it caused it. but you'd never say for certain she had her ASR implant removed, Eileen Webber is highly unusual - it was functioning reasonably well. even though mechanically

as surgeons, This is something that, I think, over the next few years. we're all going to face complications of the metal ions That, if in fact the systemic elsewhere, are causing enough problems very hard decisions then we're going to have to make about who to operate on. The jury is still out cobalt toxicity is on how widespread and dangerous in patients with metal-on-metal hips. leading surgeons like Ross Crawford, But despite the experience of Orthopaedic Association the Australian that it poses a real problem. is reluctant to embrace the idea is anecdotal at this stage. Cobalt toxicity, certainly, We are open-minded as to whether there may be an issue with cobalt toxicity in the future, but at the moment there's not the scientific evidence to support that. There's a lot of media hype about it, and I think the media hype really, at this stage, hasn't got the scientific background or evidence to actually support an issue with it. A growing number in the medical profession are now taking issue with that view. Any high cobalts today? than previously. We're seeing vastly higher levels

Anything really high? a specialist chemical pathologist, Dr Lee Price, whose blood was tested at this lab says one patient with an ASR joint had a cobalt level of 5,000 nanomoles per litre - 250 times higher than normal. We were astounded. 5,000 is, uh, as high as I've ever seen in the literature. Certainly it's the highest value that we've ever recorded. That patient is seriously toxic. At this pathology lab, growing numbers of patients with dangerously high levels of cobalt have been recorded in the last nine months. The majority have been over the normal limit of 20 nanomoles per litre. We've seen 50 patients with a level greater than 1,000 nanomoles per litre, and 500 patients greater than 100 nanomoles per litre, which is in the toxic range. And when you get up to levels greater than 1,000, then you're really in trouble. You could develop heart failure, hearing, visual loss, and I'm talking about blindness and deafness, as well as seizures, cognitive problems. So, you know, we're talking serious toxicity in a large number of patients that have received faulty hip joints. ..against both DePuy Orthopaedics and against Johnson & Johnson... Bob Lugton is now an advocate for patients whose ASR hips have failed, and he is one of hundreds of Australians who have joined class actions against DePuy and its parent company, Johnson & Johnson. What has angered patients like Bob Lugton is learning that Australia allowed the ASR hip to be marketed here, without first subjecting it to clinical trials. In actual fact the patient is the clinical trial. So, patients are virtual guinea pigs? The patients are the guinea pigs, yes. And then they, they use the result when they put them in a patient, to look at that and then decide whether it's a good hip. The Australian Orthopaedic Association's very supportive of more rigorous pre-market testing and we have been for quite some time. Ideally what we'd like to see is a minimum of two year data, independent data, before a prosthesis can be released into the market. So, it's actually tested quite extensively. That didn't happen with the DePuy ASR, which was cleared for use in Australia, on Australian patients, without the TGA testing it in any way. Doesn't the ASR experience show that more rigorous testing needs to be done before it reaches the marketplace? Quentin, there are about a million individual medical devices

available on the Australian market at the moment - that's one million. It's not possible to individually test a million medical devices, but we need those devices to improve our life span, to provide treatment, to take away the pain that patients who walk around with osteoarthritis in their hips suffer from every day.

Some of the most alarming results from research into the DePuy ASR hip have come from a small team in England. 300 miles north of London, this research has been carried out by Tom Joyce, from Newcastle University and doctors from University Hospital of North Tees. I received an email out of the blue from someone called David Langton

and he was working with a local surgeon and they had some issues with some of their patients. A group of their patients, all female at the time, had been implanted with a state-of-the-art metal-on-metal hip, the ASR. They should perform for years and years, but we were getting patients coming forward after just two or three years, reporting pain. It was... it was amazing.

The team decided to look at the problem from an engineering, as well as a clinical, perspective. If it came to the point where these joints were actually removed from patients once it had been decided they failed patients in a lot of pain, then we could take those joints, we could examine them from an engineering point of view to try and determine where those high levels of chromium and cobalt were coming from. Because we felt if we could do that

then that would explain where this pain was coming from. This equipment, known as a coordinate measurement machine, allowed the team not only to see the damage on the surface of a joint but to measure it in 3-D as well. Dave Langton and Tom Joyce believe they now know how the DePuy ASR device actually failed.

When new, these artificial hips should have a perfect mirror finish. You should be able to see your face in them, and this is needed so that the lubrication is optimised within the body. We found that those surfaces had roughened and they become excessively rough. And once that happens then the lubrication fails and essentially you have metal grinding on metal. And this, to us, explained why we had the high chromium ions - the high cobalt levels in the patients. Dave Langton and his colleagues have been warning DePuy for years that their research was uncovering high failure rates for the ASR hip and high concentrations of metal ions in some patients. The results, as soon as we had them, went straight to DePuy. All the clinical results, all the engineering results. So that was happening throughout 2008, 2009 as well.

And how did they respond? Obviously they were concerned. They were also upset as well. You know, they've got a state-of-the-art product that was not performing well, so they weren't happy. Did they concede that there was a problem with the design? Not initially, no, no. In the past few weeks alarming data collated by Dave Langton and his colleagues

has confirmed the extremely high failure rate of the Depuy ASR among their patients in Newcastle. In just over six years, 417 patients had their hips resurfaced and 26% of those hips failed. Out of 87 patients who had a total hip replacement, 49 per cent needed operations to remove them. How bad are those figures? They're terrible. They are absolutely terrible. The guidelines within the UK and what we've become accustomed to in terms of hip replacement is better than a 10% failure rate at ten years. So to have an almost one in two failure at six years is absolutely terrible. The failure rate being recorded in Australia is nowhere near the results reported in Newcastle. We do have a high risk of revision with the ASR, but our latest information for this year, the six-year data, is just under 14% for conventional ASR, and just over 11% for the ASR resurfacing hip. So, you can see we're not in the ballpark of that 49 per cent. But that difference may be due in part to the doctors in Newcastle being more aware of ASR hips that are failing, and cobalt levels that are high. Tom Joyce and Dave Langton's most recent research suggests that the problem of wear and resulting cobalt toxicity is far more widespread than the failure of just one brand, the DePuy ASR. People are now very concerned with all metal-on-metal implants and so surgeons are stopping fitting them. If your suspicions are proved to be right, how many implants worldwide are we talking about that could be affected? Hundreds of thousands. There's a massive number. For years, DePuy knew its ASR hip was failing. But only after 5,500 patients had been implanted with the device did the company decide to stop selling it in Australia, claiming this was because it was 'streamlining its hip portfolio'. Australia led the world in removing this device from the marketplace. Well, Australia didn't remove it - the company removed it. Well, the practical realities are that the device came off the market in Australia as a result of the TGA and its expert clinical groups analysing data and presenting that to the company,

making it quite clear that we regarded the performance of this device as no longer acceptable. The Australian public wasn't told the real reason for DePuy's decision in November 2009. And it took the company another nine months to announce a worldwide recall. One person who believes the recall came too late is Stephen Graves. We had some early information that it was a problem. That information was confirmed again in 2008 and 2009, and I would've thought that was enough to say that maybe there is an issue here and that it could well have been withdrawn. There seems to be a disconnect between the National Joint Register and the work it's doing on the one hand, and the TGA on the other. You'd think that there should be some cause and effect - if there is a joint that is failing time and time again, that the TGA should be alarmed about that, they should act, rather than having what seems to be a cosy arrangement with industry to ask them to voluntarily recall, which I think sends the wrong message to patients and to consumers at large. A chopper had to take you from the mid-north back to Port Adelaide? Yeah, I had systemic organ failure. That's because of the cobalt toxicity? We didn't know at the time, we didn't know, nobody knew - there was no tests done or anything. South Australian Senator Nick Xenophon knows Catherine Sullivan, and he will soon be calling for a Senate inquiry into the approvals process for medical devices in Australia. The TGA, for its part, has promised to reclassify joint prostheses

to allow a greater level of oversight, before a joint is approved. What would you say to those patients who've had this hip implanted and now are going through hell? The last thing that we as the regulator or the implanting surgeons would want is for any patient to suffer as a result of an operation. The reality is the use of medical devices is a complex interaction between the surgeon, the patient and the device involved. And the factors associated with all three parts of that relationship may come to bear on whether a particular patient suffers an adverse event. While patients have struggled to cope, the other two major players in that relationship - the company and the surgeon designer, have backed away from the controversy. Neither DePuy nor Dr Roger Oakeshott would appear on this program or answer our detailed questions. DePuy Orthopaedics sent Four Corners a one-paragraph statement, promising support to patients who need testing and treatment. Roger Oakeshott himself has gone to ground. His silence provides no comfort to those who have suffered terribly from the implants he helped to design. Did he tell you that he himself had a commercial connection with the company? No, I didn't know anything about that, no, no. There was no reason for him to tell me that, I suppose. Did he tell you that he had helped to design the hip? No! No, I didn't know that. Now that's news to me. Certainly the AOA policy would be that any doctor who implants or designs a prosthesis should notify the patient. In fact, if you look at it realistically, most surgeons who are designers of prostheses would be quite proud of the fact that they've actually designed an implant, because it's actually quite a demanding and rigorous process to look and design and then successfully implant prostheses. OK, you got the trolley? No, get your other your down, darl. Ron Barnes says that when the bursa grew on his hip he returned to Roger Oakeshott to see if anything could be done. Well done. He said, no, nothing can be done - we can just drain it for you. Did he tell you that there was anything wrong with the hip? No. He didn't tell you that the hip was faulty? No, never. Did he offer to replace it, to take it out and replace it? No, no, no. When he drained the bursa, did he send the liquid off for analysis? No. He poured it down the sink. Roger Oakeshott retired in June last year. In his downtime away from a highly successful career, Dr Oakeshott enjoyed racing fast cars, and was even once the proud owner of this car shown here being raced by Niki Lauda. In retirement, Dr Oakeshott enjoys the high-profile role of team doctor to the Adelaide netball team the Thunderbirds. But he didn't respond to an invitation from Four Corners to come out and meet three former patients of his whose hips have failed. What's your number, love? (Laughter) Like Ron Barnes, these ladies all had their operations at SportsMed, and three of them were operated on by Roger Oakeshott. Each one is grieving the loss of a previously active life.

Catherine Sullivan, Catherine Gunson, Kathy Plowright, Kay Griffiths. They had to cut my femur out or cut it away to get to the the whole thing, take it out. I had six weeks without a hip. My hip had... All the metal had formed like a tumour -

it was all wrapped around the sciatic nerve, and there was a hole in my pelvis which had to... I had to end up having a bone graft on that, and two big screws holding the cap in place. Until Four Corners invited these ladies to meet, they had no idea there were others with similar experiences, of difficult revisions, intense pain, and resultant lack of mobility. In August we had first heard about the worldwide recall and I did happen to know that I had bilateral ASR hips, because Roger had given me copies of the operating notes, because I'm a doctor. How mobile or immobile are you now? Well, I have trouble getting my shoes and socks on in the morning,

going up and down stairs. It's been nearly three months now, and still been quite a bit of pain - can't drive, can't do my housework. All aspects of my life, you know - it's just no more rock'n'rolling, no more walks - I'm just waiting to get better. Three of these ladies were Roger Oakeshott's patients. I didn't have a clue that he'd helped to design it until I came here today. What did he say when you went back to him with bursitis? Just gave me some exercises to do. Told me to sit like a man with me legs apart and walk like Charlie Chaplin and... They told me that too. Yeah. What did they tell you? Exactly the same. Because when my rheumatologist thought I had bursitis he said I should check with my surgeon whether it was safe to have a corticosteroid injection, and Roger said no, he'd rather I didn't and do all these other things. In both your cases, did he did he indicate at any point that this might be a sign there was something wrong with the hip? No, not at all. No.

I'll get you to stand up for me. Can you walk without your stick? Yeah. Back in Queensland, Ross Crawford has taken on another patient. Doug Cope had an operation last November to remove the ASR implant in his right hip. Since then, following two dislocations, he has been in constant agony.

Now I want you to stand on this leg. On this one? Yep. Yep. Basically bend that one up like that. Good, down. Now stand on this one. Hmm. I've got you. OK, it's not great is it? Doug Cope has a cobalt level of 140 nanomoles per litre - seven times higher than normal. Like many patients with an ASR hip, he was told about the recall but has no idea how and why the implant failed. Now he has just been told that he may have had two ASR's and not one, as he always thought. Oh! So you're telling me at some stage this one could pose a problem. I haven't got one, I've got two of them? Well, it looks to me, yeah, they're the same implants. So, I'm presuming they're the same implant and that's one of the mysteries, is that one is perfect and one is not, and that's one of the dilemmas we're being faced with at the moment, and you're being faced with. Oh. A former Navy man, now driven by pain, Doug chooses to spend most of his life alone on an island off the coast of Queensland, separated from his friends, and away from Wendy, his wife, suffering in solitude. I've always been tough in veneer. I played sport tough. I put up with injuries tough. But for someone to continually show misery and show pain and be heard to groan and whinge and be totally dependent on somebody else, you know, was beyond my comprehension of who I was. I wasn't stubborn. I just felt that in a lot of circumstances I just want to be on my own. What's your life like now? Oh, you know, poor, hey. Poor. The number of patients whose ASR hips have failed is still growing. All of them now, like Doug Cope are reliant not just on families, friends and GPs, but on the vision and integrity of the orthopaedic profession. There's going to be an enormous amount of research over the next years, trying to actually understand the best way to deal with this issue. It's important we don't have everyone running out tomorrow and saying, 'I need my hip out, I've got a metal hip, I'm going to have cobalt poisoning.' There are many, many hips functioning with cobalt within the normal range, and it's not something that is going to affect everybody. How big could this problem become? Well, it's already huge. We've had nearly 100,000 of these devices implanted around the world. The latest data from here in the UK suggests a potential failure rate of up to 49% at six years. So, essentially we're looking at perhaps the biggest disaster in the history of orthopaedics. That's a chilling statement for those involved. Too late for some, a mess in the making for untold others. Next week on Four Corners, what if you were told the sport you loved to play could also give you long-term brain damage? That's what the latest research is saying about contact sports like rugby league, rugby union and AFL. And that's Four Corners' investigation next week. Until then, goodnight. Close Captions by CSI