BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVEN KNEE COMPONENT

    MDR report key: 283323 · Received June 21, 2000

    Report

    Report Number
    2530191-2000-00002
    Event Type
    Malfunction
    Date Received
    June 21, 2000
    Date of Event
    May 22, 2000
    Report Date
    June 19, 2000
    Manufacturer
    STELKAST CO.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NATURE OF THE COMPLAINT: BILATERAL PRIMARY KNEES WERE IMPLANTED IN 99. THE PT WAS LARGE AND REQUIRED A 41MM DIAMETER PATELLA. NO LATERAL RELEASE WAS DONE AT THE TIME OF SURGERY. DR WATCHES THE PATELLA VERY CLOSELY BEFORE CLOSING AND IS USUALLY AGGRESSIVE IN PERFORMING A LATERAL RELEASE IF THERE ARE ANY INDICATIONS OF NON-TRACKING. THE NATURAL PATELLA WAS LARGE AND DR COULD HAVE RESECTED MORE. THE SURGERY APPEARED ROUTINE AND WITHOUT INCIDENT. SIX MONTHS LATER, PT WAS RECOVERING AND REPORTED 120 DEGREE FLEXION. FOURTEEN MONTHS AFTER IMPLANT, THE PT'S LEFT KNEE WAS SWOLLEN AND INFLAMED. DR REVISED THE KNEE IN 00 AND REMOVED THE POLY PATELLA, WHICH HAD BROKEN AWAY FROM THE CEMENT MANTEL. THE PT DID NOT REPORT FALLING OR ANY TRAUMA THAT COULD HAVE AFFECTED THE PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVEN KNEE COMPONENT KNEE / PATELLA JWH STELKAST CO. 3 PEG PATELLA 1932

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention