BEUDAMED
    FDA Adverse Event Injury Summary report: N

    25MM MOD REV HIP BDY/BLT +10MM COMPONENT LEVEL 9006

    MDR report key: 1881108 · Received October 20, 2010

    Report

    Report Number
    9616680-2010-00653
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 28, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    K013106
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "WHILE TIGHTENING THE BOLT WITH TORQUE LIMITING WRENCH. THE BOLT SNAPPED RESULTING IN EXPLANTING CONICAL STEM AND CONE BODY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 25MM MOD REV HIP BDY/BLT +10MM COMPONENT LEVEL 9006 IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA 32061801

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other