BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APR-T REVISION STEM LT 11MM

    MDR report key: 129701 · Received November 4, 1997

    Report

    Report Number
    2935620-1997-00028
    Event Type
    Injury
    Date Received
    November 4, 1997
    Date of Event
    October 6, 1997
    Report Date
    November 4, 1997
    Manufacturer
    SULZER ORTHOPEDICS, INC.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H6. METHOD: REVIEWED INSPECTION/MFG RECORDS WITH NO DISCREPANCIES FOUND. X-RAYS WERE RETURNED AND REVIEWED AND IT DOES SHOW THAT A FRACTURE OCCURRED AT THE LEVEL OF ONE OF THE CERCLAGE WIRES IN THE REGION OF THE METAPHSIS, BUT THE EXACT LOCATION OF THE FRACTURE CANNOT BE DETERMINED. H6. RESULTS: SUFFICIENT DATA HAS NOT BEEN MADE AVAILABLE TO DETERMINE ACTUAL CAUSE FOR FAILURE AT THIS TIME. IF/WHEN ADDITIONAL DATA OR PRODUCT IS MADE AVAILABLE, THEN A FOLLOW-UP REPORT WILL BE PROVIDED. STEM HAS NOT BEEN REVISED AT THIS TIME.

    Description of Event or Problem · 1

    SALES AGENT NOTIFIED SULZER ORTHOPEDICS INC. OF AN APR-T REV. STEM THAT BROKE. DEVICE EXPLANTED AND RETURNED TO SULZER ORTHOPEDICS INC. ON 04/23/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APR-T REVISION STEM LT 11MM Implant HIP STEM PROSTHESIS KWY SULZER ORTHOPEDICS, INC. NA 1151422-A

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| O| R