BEUDAMED
    FDA Adverse Event Injury Summary report: N

    78/74 A/P L FEMORAL

    MDR report key: 270112 · Received March 21, 2000

    Report

    Report Number
    1818910-2000-00055
    Event Type
    Injury
    Date Received
    March 21, 2000
    Date of Event
    February 23, 2000
    Report Date
    March 21, 2000
    Manufacturer
    DEPUY-RAYNHAM, DIV. OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS REVISED DUE TO A BROKEN CONDYLE ON THE FEMORAL IMPLANT.

    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 7U70

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention