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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUYDEPUY ARTICUL / EZE M-SPEC FEMORAL HEAD

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DEPUY DEPUY ARTICUL / EZE M-SPEC FEMORAL HEAD   Back to Search Results
Event Date 12/30/2010
Event Type  Injury   Patient Outcome  Disability
Event Description

Both my hips have been replaced: right on (b)(6) 2006 and left on (b)(6) 2007 using the same parts as listed. Depuy pinnacle acetabular cup, depuy apex hole eliminator, depuy pinnacle cancellous bone screw -2-, depuy summit tapered hip stem w/ porocoat, depuy articul/eze m-spec femoral head, zimmer soft tissue attachment device. This was a metal on metal system that was supposed to last the rest of my life. During the (b)(6) of 2008, my left hip started to hurt and i made an appointment to go to (b)(6) clinic where the hip was done to have it checked. I was told it was bursitis and given a shot. I limped around in pain for another year, sure that i had done something wrong. I would have to pick up my left leg to get into my truck. Finally, in (b)(6) of 2010, i asked my regular doctor at (b)(6) if she could arrange another cortisone shot for my left hip. X-rays were taken of both hips and i got another shot. The pain continued to increase but we had gone back to (b)(6) for the summer. I made an appointment with a local orthopedist who set me up to get an mri. The mri showed fluid collecting around both hips. I decided to wait and return to (b)(6) with the mri when we went back for the winter. I was sent to have blood work and hip x-rays. When i returned to the doctor, i was told that my left hip was no longer in place and my chromium level was 72. 4 - normal. 03-. An aspiration of the fluid around the left hip and revision surgery were both scheduled. The doctor told me that the hip joint was just floating around with cobalt, chromium, and titanium debris depending on the location. I am now in the painful, boring part of recovery and still have to deal with the right hip. I have already wasted 5 years of my life in pain. No one knows what the final effect of metallosis will have, but one can assume it will not prolong life. Why haven't all the depuy metal on metal hip replacement products been recalled? i will have extensive physical therapy when the joint is cleared for weight bearing.

 
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Brand NameDEPUY ARTICUL / EZE M-SPEC FEMORAL HEAD
Type of DeviceFEMORAL HEAD
Manufacturer (Section F)
DEPUY
Manufacturer (Section D)
DEPUY
Device Event Key1990008
MDR Report Key1959834
Event Key1856830
Report NumberMW5018944
Device Sequence Number6
Product CodeKXA
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/09/2011
7 DeviceS WERE Involved in the Event:1 2 3 4 5 6 7 
1 Patient Was Involved in the Event
Date FDA Received01/09/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Service Personnel
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?

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