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Adverse Event Report

DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC PFC MOD. KNEE SYSTEM POSTERIOR LIPPED TIBIAL INSERT TOTAL KNEE REPLACEMENT   back to search results
Catalog Number 864619
Device Problems Component(s), worn; Implant, removal of
Event Date 01/14/2003
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Patient revised due to early poly wear.

 
Manufacturer Narrative

This complaint is still under investigation.

 
Search Alerts/Recalls

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Brand NamePFC MOD. KNEE SYSTEM POSTERIOR LIPPED TIBIAL INSERT
Type of DeviceTOTAL KNEE REPLACEMENT
Baseline Brand NamePFC PLI 15MM SZ4
Baseline Generic NamePOSTERIOR LIPPED TIBIAL INSERT
Baseline Catalogue Number864619
Baseline Device FamilyPFC MODULAR KNEE SYSTEM TIBIAL INSERT
Baseline Device 510(K) NumberK830927
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed07/08/1983
Manufacturer (Section F)
DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC
325 paramount drive
raynham MA 02767 0350
Manufacturer (Section D)
DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC
325 paramount drive
raynham MA 02767 0350
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer Contact
ginny stamberger, mgr.
700 orthopaedic drive
warsaw , IN 46581-0988
(574) 372 -7333
Device Event Key526393
MDR Report Key537158
Event Key509977
Report Number1818910-2004-00533
Device Sequence Number1
Product CodeJWH
Report Source Manufacturer
Source Type Distributor,Other
Reporter Occupation ATTORNEY
Remedial Action Other
Type of Report Initial
Report Date 07/26/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/29/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number864619
Device LOT Number20877A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/26/2004
Device Age4 yr
Event Location Hospital
Date Manufacturer Received07/26/2004
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/1997
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

Database last updated on January 30, 2009

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