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

Catalog Number 00576201451

Device Problems Loose; Implant, removal of

Event Date 06/21/2010

Event Type  Injury   Patient Outcome  Required Intervention

Event Description

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

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.

• Brand Name: NEXGEN LPS-FLEX GSF FEMORAL COMPONENT
• Type of Device: KNEE 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 Key: 1803510
• MDR Report Key: 1765427
• Event Key: 1674823
• Report Number: 1822565-2010-00499
• Device Sequence Number: 1
• Product Code: JWH
• 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 Received: 07/20/2010
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Health Professional
• Device EXPIRATION Date: 10/31/2018
• Device Catalogue Number: 00576201451
• Device LOT Number: 61054861
• 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 Received: 06/22/2010
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 11/01/2008
• 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

#	Treatment	Treatment Date
NEXTGEN ZIMMER MINIMALLY INVASIVE SOLUTIONS
PROCEDURES TRABECULAR METAL TECHNOLOGY TIBIAL
TRAY, CATALOG #00595403701, LOT# 61277195