BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 1942065 · Received December 23, 2010

    Report

    Report Number
    1942065
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    December 20, 2010
    Report Date
    December 21, 2010
    Manufacturer
    UNK
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD PRIOR LEFT KNEE TOTAL ARTHROPLASTY (DATE OF SURGERY UNK). PRESENTED WITH PAIN AND FOUND TO HAVE KNEE RECURVATUM AND KNEE INSTABILITY. DX - MECHANICAL FAILURE OF ARTHROPLASTY. ON DATE OF EVENT, PT HAD ARTHROPLASTY REVISION COMPLETED WITH REMOVAL/REPLACEMENT OF TIBIAL INSERT. PER PATHOLOGY GROSS EXAMINATION, DEVICE REMOVED WAS 7.5 X 4.5 X 2.3 CM, WHITE HARD, SOLID PLASTIC WITH CRACKING AND ROUGHNESS ALONG ONE SURFACE AND RAISED AND CRACKED PLASTIC ALONG OPPOSITE SURFACE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN TIBIAL INSERT OF TOTAL KNEE IMPLANT JWH UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other