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Adverse Event Report

DEPUY-RAYNHAM, DIV. OF DEPUY ORTHOPAEDICS, INC. PFC MODULAR KNEE SYSTEM POSTERIOR LIPPED TIBIAL INSERT TOTAL KNEE PEOSTHESIS   back to search results
Catalog Number 86-4608
Device Problem Implant, removal of
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Received an explanted pfc tibial tray with a crack across one side of the platform.

 
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Brand NamePFC MODULAR KNEE SYSTEM POSTERIOR LIPPED TIBIAL INSERT
Type of DeviceTOTAL KNEE PEOSTHESIS
Baseline Brand NamePFC PLI 8MM SZ3
Baseline Generic NamePOSTERIOR LIPPED TIBIAL INSERT
Baseline Catalogue Number864608
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 Marketed08/16/1986
Manufacturer (Section F)
DEPUY-RAYNHAM, DIV. OF DEPUY ORTHOPAEDICS, INC.
325 paramount drive
raynham MA 02767
Manufacturer (Section D)
DEPUY-RAYNHAM, DIV. OF DEPUY ORTHOPAEDICS, INC.
325 paramount drive
raynham MA 02767
Manufacturer Contact
hans kusserow, mgr.
700 orthopaedic dr
warsaw , IN 46581-0988
(219) 372 -7416
Device Event Key232490
MDR Report Key239936
Event Key225113
Report Number1818910-1999-00142
Device Sequence Number1
Product CodeJWH
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation UNKNOWN
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 09/16/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/16/1999
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number86-4608
Device LOT NumberL574
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/20/1999
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/23/1999
Device Age8 yr
Event Location Hospital
Date Manufacturer Received08/23/1999
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/1991
Is The Device Single Use? Yes
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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