BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-025

    MDR report key: 3103338 · Received May 9, 2013

    Report

    Report Number
    0002249697-2013-01604
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K040734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CRACK/FRACTURE INVOLVING A RESTORATION MODULAR BOLT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE DEVICE WAS NOT RETURNED. INSUFFICIENT INFORMATION WAS RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED, FURTHER INFORMATION IS NEEDED.

    Description of Event or Problem · 1

    THE BOLT SCREW FOR THE REST MOD BODY TO STEM BROKE WHILE CONNECTING TO THE STEM BEFORE TORQUING. WE WERE UNABLE TO REMOVE THE STEM CONSTRUCT AND DECIDED TO LEAVE IT ALONE.

    Description of Event or Problem · 1

    THE BOLT SCREW FOR THE REST MOD BODY TO STEM BROKE WHILE CONNECTING TO THE STEM BEFORE TORQUING. WE WERE UNABLE TO REMOVE THE STEM CONSTRUCT AND DECIDED TO LEAVE IT ALONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203023 25MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-025 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH 42830401

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other