BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVANCE

    MDR report key: 37328 · Received September 4, 1996

    Report

    Report Number
    37328
    Event Type
    Other
    Date Received
    September 4, 1996
    Date of Event
    August 19, 1996
    Report Date
    August 30, 1996
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    7/15/96 UNDERWENT BILATERAL TOTAL KNEE REPLACEMENT. 8/5/96 UNDERWENT INCISION AND DRAINAGE OF LEFT KNEE FOLLOWING X-RAY WHICH SHOWED POLY. INSERT DISLOCATION, AND SEROSANGINOUS DRAINAGE. PT ADMITTED FALLING AFTER TKR ON 7/15/96. IDENTICAL INSERT REPLACED DISLOCATED INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE Implant POSTERIOR STABILIZED TIBIAL INSERT JWH WRIGHT MEDICAL TECHNOLOGY, INC. NI 056A045533

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other ADVANCE COBALT CHROME TIBIAL BASE NON-POROUS COATE| ADVANCE TOTAL KNEE SYSTEM, ALL POLY PATELLA,| NON-POROUS, AND SURGICAL SIMPLEX P| ADVANCE TOTAL KNEE SYSTEM, POST. STAB. FEMORAL NON