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Adverse Event Report

ENCORE MEDICAL, L.P. ENCORE KNEE REPLACEMENT SYSTEM KNEE IMPLANT   back to search results
Model Number 360-13-006
Device Problem Device breakage
Event Date 03/24/2003
Patient Outcome  Required Intervention;
Event Description

The tibial post was broken at it's base and the femoral, tibial, and patellar components were well cemented and well seated with no evidence of loosening with visual palpation inspection.

 
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Brand NameENCORE KNEE REPLACEMENT SYSTEM
Type of DeviceKNEE IMPLANT
Baseline Brand NameFOUNDATION KNEE SYSTEM
Baseline Generic NameFOUNDATION TIBIAL INSERT
Baseline Catalogue Number360-13-006
Baseline Device FamilyFOUNDATION PS TIBIAL INSERT
Baseline Device 510(K) NumberK933539
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed11/01/1994
Manufacturer (Section F)
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin TX 78758
Manufacturer (Section D)
ENCORE MEDICAL CORP. ENCORE ORTHOPEDICS
9800 metric blvd
austin TX 78758
Device Event Key443584
MDR Report Key454582
Event Key430576
Report Number454582
Device Sequence Number1
Product CodeHRY
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 04/10/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/15/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device MODEL Number360-13-006
Device LOT Number907761 TIBIAL INSERT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/31/2003
Event Location Home
Date Report TO Manufacturer04/10/2003
Is the Device an Implant? Yes
Is this an Explanted Device?

Database last updated on February 28, 2009

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