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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC ZIMMER VERSYS HIP SYSTEM FEMORAL HEAD

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ZIMMER, INC ZIMMER VERSYS HIP SYSTEM FEMORAL HEAD Back to Search Results
Catalog Number OR REF # 8018-28-02
Event Date 06/26/2008
Event Type  Injury  
Event Description

I fell and slipped in (b) (6) 2008. My femoral head was broken and i had surgery on (b) (6) 2008. The following medical device has been used in my hip joint: lot # 60816008, (b) (4), (b) (4). Since the medical device has been used in my hip joint, i have got severe pain and i suffered a broken hip replacement. The surgery and that medical device have resulted in ongoing arthritic changes causing pain through the hip joint. It should be noted that the surgical procedure involved a zimmer brand replacement, and zimmer has issued a number of recalls relative to the joint in question. I have been evaluated by dr (b) (6). I have significant pain and my doctor has recognized that future my joint is subject to a failure. Pursuant to announcement of fda the same medical device has been recalled by fda on november 13, 2009 zimmer inc. The recall medical device that fda has announced, is lot # 60378581 and edi number and rer number are the same medical device that has been implanted in my joint. Only lot numbers are different. Although the medical device that has been implanted in my joint, has created severe pain and suffering in my joint, could you please investigate whether the medical device that has been used in my hip joint, is a recall medical device? i believe that zimmer might have made error about the recall's lot number. I anticipate that fda would investigate about lot number. I will appreciate your response. Thanks. (b) (6). Dates of use: almost 2 years, (b) (6) 2008--(b) (6) 2010. Diagnosis or reason for use: femoral head was broken in fall & slip.

 
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Brand NameZIMMER
Type of DeviceVERSYS HIP SYSTEM FEMORAL HEAD
Manufacturer (Section F)
ZIMMER, INC
1777 w center st
warsaw IN 46580
Manufacturer (Section D)
ZIMMER, INC
1777 w center st
warsaw IN 46580
Device Event Key1767200
MDR Report Key1723168
Event Key1635840
Report NumberMW5016313
Device Sequence Number1
Product CodeKWY
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/09/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/09/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberOR REF # 8018-28-02
Device LOT Number60816008
OTHER Device ID NumberEDI # 00801802802
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 06/09/2010 Patient Sequence Number: 1
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