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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC.NEXGEN LPS-FLEX GSF FEMORAL COMPONENTKNEE PROSTHESIS

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ZIMMER, INC. NEXGEN LPS-FLEX GSF FEMORAL COMPONENT KNEE PROSTHESIS   Back to Search Results
Catalog Number 00576201451
Device Problems Loose; Implant, removal of
Event Date 06/21/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

Evaluation summary: no product was returned for evaluation. Also, no x-rays or operative notes were returned for review. Patient health, medical history, activity level and conformance to the rehabilitation regimen can contribute to the success or failure of any implanted device - none of which are known in this case. Based on the available information, a definitive root cause cannot be ascertained at this time. No product was returned. Review of the device history records did not find any deviations or anomalies. 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 investigation, 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.

 
Event Description

It is reported that the patient was revised due to pain and loosening.

 
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Brand NameNEXGEN LPS-FLEX GSF FEMORAL COMPONENT
Type of DeviceKNEE PROSTHESIS
Manufacturer (Section F)
ZIMMER, INC.
p.o. box 708
warsaw IN 46581 0708
Manufacturer (Section D)
ZIMMER, INC.
p.o. box 708
warsaw IN 46581 0708
Manufacturer Contact
kevin escapule
p.o. box 708
warsaw , IN 46581-0708
(800) 613 -6131
Device Event Key1803510
MDR Report Key1765427
Event Key1674823
Report Number1822565-2010-00499
Device Sequence Number1
Product CodeJWH
Report Source Manufacturer
Source Type Distributor,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 06/22/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/20/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date10/31/2018
Device Catalogue Number00576201451
Device LOT Number61054861
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received06/22/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/20/2010 Patient Sequence Number: 1
#TreatmentTreatment Date
NEXTGEN ZIMMER MINIMALLY INVASIVE SOLUTIONS
PROCEDURES TRABECULAR METAL TECHNOLOGY TIBIAL
TRAY, CATALOG #00595403701, LOT# 61277195
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