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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER INC NEXGEN GSF CR-FLEX FEMORAL COMPONENT KNEE PROSTHESIS

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ZIMMER INC NEXGEN GSF CR-FLEX FEMORAL COMPONENT KNEE PROSTHESIS Back to Search Results
Device Problem Detachment Of Device Component
Event Date 10/04/2007
Event Type  Injury  
Event Description

It was reported that the pt's knee was revised due to pain and loosening.

 
Manufacturer Narrative

Evaluation summary: no devices or photos were received; therefore the condition of the components is unk. Neither surgical notes nor x-rays were provided, therefore fit and orientation could not be evaluated. Pt factors that may affect the performance of the components such as bone quality, activity level or type of activity (low impact vs. High impact) are unk. A definitive root cause cannot be determined with the information provided. Evaluation: review of the device history records was not possible as the product and/or lot numbers required for retrieval were unavailable. It is not suspected that the product failed to meet specifications. The investigation could not verify or identify any evidence of product contribution to the reported problem. Based on the available information, the need for corrective action is not indicated. Should additional substantive information be received, the complaint will be reopened. Zimmer, inc. Considers the investigation closed.

 
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Brand NameNEXGEN GSF CR-FLEX FEMORAL COMPONENT
Type of DeviceKNEE PROSTHESIS
Manufacturer (Section D)
ZIMMER INC
p.o. box 708
warasw IN 46581 070
Manufacturer Contact
kevin escapule
p.o. box 708
warsaw , IN 46581-0708
8006136131
MDR Report Key2666862
Report Number1822565-2012-01507
Device Sequence Number1
Product CodeJWH
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/18/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/18/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received06/18/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/18/2012 Patient Sequence Number: 1
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