BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI-LOCK BPS SZ 6 HI OFFSET

    MDR report key: 1945207 · Received December 30, 2010

    Report

    Report Number
    1818910-2010-10765
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 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
    NH, 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

    PT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL STEM. IT WAS REPORTED THAT THE PT HAD AN UNNOTICED FRACTURE AT THE TIME OF PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRI-LOCK BPS SZ 6 HI OFFSET 87KWA; 87LZO; 87LPH KWA DEPUY ORTHOPAEDICS, INC. NA D56E11

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention