BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REUNION TSA - MODULAR NECK ADAPTER TRIAL

    MDR report key: 3051305 · Received April 10, 2013

    Report

    Report Number
    0002249697-2013-01239
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A FRACTURED REUNION TSA MODULAR NECK ADAPTOR TRIAL WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: A VISUAL INSPECTION CONFIRMED THE EVENT. AN MAR INDICATED THE PART BROKE FROM SIDE LOADING, LEADING TO A BREAK IN OVERLOAD. NO MATERIAL OR MANUFACTURING DEFECTS WERE IDENTIFIED. A MATERIAL ANALYSIS CONCLUDED, "THE PART BROKE FROM A SIDE LOADING CAUSING THE PAT TO BREAK IN OVERLOAD. THE BASE MATERIAL WAS FOUND TO BE A POLYETHERIMIDE WITH BARIUM SULFIDE ADDED TO THE POLYMER. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED." MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS PATIENT FACTORS DID NOT CONTRIBUTE TO THE EVENT. DEVICE HISTORY REVIEW: NOT PERFORMED AS THE DEVICE IS NOT LOT CODED. COMPLAINT HISTORY REVIEW: NOT PERFORMED AS THE DEVICE IS NOT LOT CODED. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE DEVICE BROKE FROM OVERLOADING CONDITIONS. NO MATERIAL OR MANUFACTURING DETAILS WERE IDENTIFIED. IT IS BELIEVED THAT THE FAILURE OCCURRED DURING OFF AXIS LOADING DURING USE. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    TRIAL MODULAR NECK ADAPTOR PIECE SHEERED OF DURING TRIAL REDUCTION. THERE ARE TWO TRIAL MODULAR NECKS IN THE INSTRUMENT SET.

    Description of Event or Problem · 1

    TRIAL MODULAR NECK ADAPTOR PIECE SHEERED OF DURING TRIAL REDUCTION. THERE ARE TWO TRIAL MODULAR NECKS IN THE INSTRUMENT SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152787 REUNION TSA - MODULAR NECK ADAPTER TRIAL INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other