BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI-LOCK BPS SZ 12 HI OFFSET

    MDR report key: 1822883 · Received August 25, 2010

    Report

    Report Number
    1818910-2010-05600
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 26, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    K073570
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM, WHICH HAD FAILED TO ACHIEVE PROPER INGROWTH, RESULTING IN SUBSIDENCE, PAIN, AND INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRI-LOCK BPS SZ 12 HI OFFSET 87KWA, 87LZO, 87LPH KWA DEPUY ORTHOPAEDICS, INC. NA C3WC11000

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention