BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL BODY REMOVAL DEVICE

    MDR report key: 5127065 · Received October 5, 2015

    Report

    Report Number
    0002249697-2015-03239
    Event Type
    Malfunction
    Date Received
    October 5, 2015
    Date of Event
    September 8, 2015
    Report Date
    September 8, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS EVENT RELATES TO AN OFF LABEL USE INVOLVING A RESTORATION MODULAR EXTRACTOR AND UNKNOWN NON-STRYKER HIP COMPONENT/COMPONENTS. BASED ON THE PROVIDED INFORMATION IT HAS BEEN DETERMINED THAT THIS EVENT IS ASSOCIATED WITH AN OFF-LABEL APPLICATION. A REVIEW OF THE MOST RECENT PACKAGING INSERT IFU, QIN 4382 REV D, INDICATES THAT HOWMEDICA OSTEONICS INSTRUMENTATION CONSISTS OF MANUAL SURGICAL INSTRUMENTS INTENDED FOR USE DURING HIP, KNEE, SHOULDER, ELBOW OR WRIST ARTHROPLASTY, OR TRAUMA SURGERIES. UNDER THE WARNINGS SECTION OF THE INSTRUCTIONS FOR USE IT STATES THE FOLLOWING: DUE TO DIFFERENT MANUFACTURERS EMPLOYING DIFFERING DESIGN PARAMETERS, VARYING TOLERANCES, DIFFERENT MATERIALS AND MANUFACTURING SPECIFICATIONS, HOWMEDICA OSTEONICS INSTRUMENTATION SHOULD NOT BE USED TO IMPLANT ANY OTHER MANUFACTURER¿S COMPONENTS. ANY SUCH USE WILL NEGATE THE RESPONSIBILITY OF HOWMEDICA OSTEONICS CORP. FOR THE PERFORMANCE OF THE RESULTING IMPLANT. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DOING A REVISION ON PATIENT'S RIGHT HIP (NOT A REVISION OF STRYKER PRODUCT) SURGEON WAS USING THE TRIAL BODY REMOVAL DEVICE WITH A MALLETT AND THE HOOK PART ON BOTTOM OF THE REMOVAL DEVICE BROKE OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DOING A REVISION ON PATIENT'S RIGHT HIP (NOT A REVISION OF STRYKER PRODUCT) SURGEON WAS USING THE TRIAL BODY REMOVAL DEVICE WITH A MALLETT AND THE HOOK PART ON BOTTOM OF THE REMOVAL DEVICE BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658999 TRIAL BODY REMOVAL DEVICE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other