BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    78/74 A/P L FEMORAL

    MDR report key: 290087 · Received August 14, 2000

    Report

    Report Number
    1818910-2000-00210
    Event Type
    Malfunction
    Date Received
    August 14, 2000
    Date of Event
    May 18, 2000
    Report Date
    August 14, 2000
    Manufacturer
    DEPUY RAYNHAM / DIV. OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FEMORAL CONDYLE WAS BROKEN. PT SAYS THAT THE KNEE LOCKED UP ON 11-02-97. AFTER THAT, THE PT FELT THAT THE PIECES WERE LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 78/74 A/P L FEMORAL TOTAL KNEE PROSTHESIS HSA DEPUY RAYNHAM / DIV. OF DEPUY ORTHOPAEDICS, INC. NA 036506

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other