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Event Date 09/27/2007
Event Type  Injury  
Event Description

Add'l info received from reporter (b)(6) 2011: this is a follow-up on my previous report- so i am hoping you do not need a full recounting of the surgery event in (b)(6) of my original hip implant. I wanted to give the fda an update on my situation. I had the pinnacle hip implant installed in (b)(6) 2007, and again, have had nothing but pain and problems with it, all non-contributory on my part. I had heavy metal chromium and cobalt blood tests performed in late (b)(6), 2007 as well as recent ones in (b)(6) 2011. All tests came back "off the charts" according to my orthopedic surgeon- in other words, extremely high. -cobalt in the 1st test- 37. 0 mcg/liter, and chromium, 27. 9 mcg/liter. I scheduled a 2nd revision surgery with a doctor in (b)(6) in early (b)(6), 2011, and i am now recovering from it. He handed the depuy pinnacle acetabular cup and bearing over to my brother and my cousin in the waiting room on (b)(6). He then indicated to them that my device was noticeably worn, had given off fragments and shards of metal into my soft tissue, (visible to him at the time of my surgery last week), and had injured or destroyed bone and soft tissue in my right hip. The surgeon also indicated that the device was clearly responsible for the blood poisoning of my bloodstream. (i have developed hypothyroidism in the last 12 months, loss of hearing, vision, and have had numerous tremors and shakes as well as times of confusion and forgetfulness. ) he inserted a depuy ceramic bearing, (which is apparently interchangeable with the long stem in my femur), and also put in a ceramic acetabular cup which will hopefully eliminate all of the heavy metal blood poisoning. I am in home recovery at this time with a lot of pain and swelling, and am restricted to a walker. I am worried at this point of permanent damage to my internal system, as well as the vision loss issues, and how it will all impact my life and my future. I am a commercial airline transport pilot and am concerned that physical damage to my eyesight, among other problems, will prevent me from flying again. The (b)(6) has very tight restrictions, especially when trying to get the 1st class medical, which i must hold to perform my job. There is no doubt in my mind that i have been injured by this pinnacle metal on metal hip replacement, with some of the after effects, probably lasting me for life. I will need to continue getting (b)(6) blood tests for years to see if these cobalt/chromium blood levels come down anywhere near to normal. The kidneys and liver can only do so much to rid the body of these dangerous metals, but i have been warned i may never get it all out of my internal organs. That, most assuredly, is not a happy thought for me. I will never be able to fully assess the permanent damage and stress on my internal "filter" organs these contaminants have caused my body, and will more than likely result in a premature death for me at sometime down the road, which i am near certain, will be erroneously written off to "old age," by people other than my family. I am asking the fda once again, to please take this product off the market. It is dangerous and is clearly injuring people throughout our country. I implore you to recall this pinnacle metal on metal hip device as soon as possible if not sooner. I consider myself living proof of its' defects and the injuries it can cause in peoples' bodies, not to mention their lives. I have been grounded from aviation since my "lock-up" at (b)(6) and (b)(6) terminals, in (b)(6) 2010, long before the recall of the asr, which is clearly near the mirror image of the pinnacle. I nearly had to file bankruptcy and foreclosure proceedings had it not been for a charitable contribution by the pilot group in my company because of my extreme circumstances. Both the asr and the pinnacle have a lot in common and are clearly dangerous to the bloodstream in human beings. The pinnacle has no business being on the market, in my opinion.

Event Description

Additional info received from reporter on 10/22/2010. This is a follow-up report from the one i filed recently as a complaint against the depuy/j&j pinnacle hip implant. As stated before, i had my hip replaced in (b)(6) on (b)(6) 2007. After a long rehab and pt until (b)(6) 2008, i returned to work as a commercial aircraft pilot. Starting only 2 months after my pt, i experienced on and off severe pain at the site of the implant, severe groin pain, right thigh pain, limited mobility, a constant popping noise as well as snapping back and forth into position after just performing basic maneuvers such as tying my shoes or leaning over to brush my teeth over the sink. When i try to return to an erect position, there is a def feeling of catching and pulling, metal to metal grinding sounds, followed by a snap back into position of the device between the acetabular cup and the top of the stem. Accompanied by any of these movements are severe pain between levels 6-8, with momentary nausea, which would subside once stationary. My job as a pilot was severely restricted as in needing assistance loading passengers' bags into the cargo compartment. Every time i carefully got into or out of the pilot's seat of the citation jet that i fly, i experienced severe pain which would last up to 20 minutes, interfering with my ability to fly safely. I started physical therapy again on my hip, which was in vain, in 2009. My problems with limited mobility and range of motion became extreme in (b)(6) and (b)(6) of 2010. I tried to control the pain with advil and other over the counters to avoid being on narcotic drugs like hydrocodone, which were suggested by my doctors. The faa does not allow pilots to be on such drugs, so i did my best to continue working, on advil, with obvious difficulty noted by fellow pilots. I cannot do some of the physical exertions required by my airline without assistance. The important thing to note here, is that i took very good care of my hip from the time i came out of initial rehab in 2008, never doing anything to damage it or injure myself. I gave up many activities to maintain it's integrity, because i had no intention of ever going back under the knife for another hip replacement, an experience i would not wish on my worst enemy. On (b)(6) 2010, i left for work in level 6 pain in my hip, but pressed on anyway, because i was trying to avoid going on disability at 60% pay, and risking foreclosure on my home. I noticed severe pain that morning just walking through the terminal at (b)(6), my homebase. I got on a (b)(6) to connect to another flight to (b)(6) to pick up my jet for a trip. Once getting off the plane at (b)(6) to walk to my connecting gate, i could barely walk, and was offered help from passengers. I declined and held onto a pole in the terminal in uniform for 10 minutes, waiting for the sharp pain to subside, trying not to draw attention to myself as a commercial pilot clearly in pain. I sat down at that gate, and called my airline about my situation and they booked me back to (b)(6). They put me on sick call, and i returned to (b)(6)hours later. After getting off the plane at (b)(6), i experienced level 10 sharp, stabbing pains like i have never felt in my life, and stopped in mid stride with my hip locked up in the middle of the terminal walkway. I nearly passed out, and tears came to my eyes from the pain. I was assisted by passengers to the men's' room where i was nauseous for 3 minutes from the pain. I was assisted back out into the terminal and a cart driven by airport personnel took me to the airport exit where, i was picked up by a (b)(6)signature (b)(6) and helped into it. The driver asked me if i needed to go to the hospital. I declined, stating that i just needed to get to my car and would put it on cruise control to the (b)(6) hosp ctr in (b)(6). My drive was excruciating. I went to the emergency room, and was diagnosed with possible hip strain, possible implant failure, and was sent home on crutches. I then went on disability, and went through more physical therapy. I could not support my weight at all on my right leg. I need to be able to hold between 100-200 lbs of rudder pressure in my jet in case of an engine failure on take-off to counter asymmetric thrust, and prevent the jet from rolling over on its' back. I can leg press 260 lbs with my left leg. I cannot get up anything over 40 lbs with my right. I put my home up for rent in (b)(6) to avoid foreclosure on reduced pay, and then moved in with my mother in (b)(6). My tenants moved out in the middle of the night in (b)(6), and i made every attempt to go back to work to get on full pay, pain or not. I became aware of the depuy asr recall, which is also a metal to metal implant, and my doctor and family in (b)(6), 2010, urged me to get a blood test screening for cobalt/chromium blood poisoning from the device. I borrowed money from my aunt in (b)(6) to pay my (b)(6) mortgage. I got a special blood test at (b)(6) on (b)(6) 2010 screening for cobalt/chromium poisoning, and they both came back way over normal limits on (b)(6) 2010, assayed twice to be sure. As a result, i am back on disability with my home up for short sale to avoid foreclosure. But it will probably foreclose anyway since i cannot find a buyer. I have also gotten blood tests indicating an elevated figure for my thyroid, -never had any problems ever with this before,- a condition called hypothyroidism, which is evidently an after effect of cobalt poisoning. I have other symptoms of metal poisoning as well, such as vision loss, and some trembling in my hands. I have consulted 2 orthopedic surgeons who agreed that the device must be removed and perhaps get a on metallic device implanted, namely the old ceramic type. This will ground me for a long time, and my job is in serious jeopardy again, not to mention my quality of life- which has seriously declined in the last (b)(6) due to this defective pinnacle implant. I am about to schedule an appointment with a surgeon to have it removed to prevent any further serious damage to my internal organs and nervous system. Time is of the essence at this point. I am requesting that your organization please recall this pinnacle implant. Dates of use: (b)(6) 2007 - (b)(6) 2010. Diagnosis or reason for use: osteoarthritis in right hip required thr.

Event Description

Had arthritis in my rt hip and had hip totally replaced at (b)(6), on (b)(6)2007. Device implanted was mfg by depuy/johnson & johnson. Type is pinnacle with "acetabular cup size 54 mm. " after 8 months of rehab, experienced constant pain and range of motion problems with hip requiring physical therapy, to today's date, (b)(6)2010. Worst experience with device was on (b)(6)2010 while attempting to go to work. I am a (b)(6) and was reporting in uniform to work at (b)(6). I was experiencing level 8 pain and limited range of motion just walking through the (b)(6) at (b)(6). After getting off the plane in (b)(6), my hip "locked up" twice and i needed assistance walking to a chair from unk passengers. I called my company and they put me on sick call and put me on a flight back to (b)(6). At (b)(6), i experienced severe level 10 pain that i have never felt in my life, hip completely locked up, was nauseous in the men's room, and was assisted by (b)(6) in a cart to a waiting (b)(6) from (b)(6) to my car, whereupon i drove myself to (b)(6) hospital ctr in (b)(6) and was admitted to their er. I was placed on crutches with a diagnosis of hip strain and possible device failure. I was placed on short term disability and received extensive physical therapy, spending my waking hours on a cane. X-rays surprisingly showed no device failure, but i have learned that this is a common result by many similar sufferers. I returned to work on (b)(6)2010 only because my 6 month disability on 60% pay was ending, and then i was left with no choice but to go on long term at the same pay rate. I was faced with personal bankruptcy and mortgage foreclosure, and was forced to go back to work, but only for those reasons which are, of course, personal and financial. I returned to work as a (b)(6) to our hq in (b)(6), (b)(6) only during ground school/recurrent training. I was in pain out there the entire time, and used a cane privately in the hotel, limping in public during class. I am trying to keep my job (b)(6) on full pay, but am in fear of not being able to hold right (b)(6) pressure upwards of 200 lbs during my upcoming (b)(6), where there is an important phase where you lose (b)(6) and must use, perhaps, hard right (b)(6) pressure to counter the asymmetric thrust to prevent the (b)(6) from rolling over on its back. I had physical therapy again yesterday on (b)(6), which was sorely needed, but i am still in pain today and am worried about my upcoming class back in (b)(6) on (b)(6) for simulator training where i will be faced with the scenarios described above. I am angry at depuy, j&j corps, et al, after hearing of the model asr recall, and from what i can ascertain, the pinnacle model, with the shallow receiver cup, is virtually identical. I have all the symptoms of the complaints filed against the asr model. Mine clicks, pops, grinds, locks up "stretches, then gives" causing major shooting pains in my right leg. I am getting blood tests to determine possible bloodstream contamination of the device, since it is also metal to metal, and there are reports of cobalt and chromium entering complainants' bloodstreams. I am near certain i will need another hip replacement, painful and debilitating for at least a year the 2nd go round, and i believe my job in likewise in jeopardy, again. I have been (b)(6) for over 30 years, including the (b)(6), and do not want to have to retire early because of this defective implant receiver cup.

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Manufacturer (Section D)
p.o. box 988
warsaw IN 46681
MDR Report Key1848607
Report NumberMW5017597
Device Sequence Number3
Product CodeKWA
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 09/24/2010
6 DeviceS WERE Involved in the Event: 1   2   3   4   5   6  
1 Patient Was Involved in the Event
Date FDA Received09/24/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Is this a Reprocessed and Reused Single-Use Device? No

Date Received: 09/24/2010 Patient Sequence Number: 1