BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMRS EXT TRIAL PIECE 40MM

    MDR report key: 3030261 · Received April 2, 2013

    Report

    Report Number
    0002249697-2013-01161
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO REPORTED DISCREPANCIES AND THERE WERE NO OTHER EVENTS FOR THE REFERENCED LOT. DIMENSIONAL INSPECTION INDICATED THAT THREE IGS FEATURES WERE OUT OF SPECIFICATION. NO MEDICAL RECORDS WERE RECEIVED AND NONE EVALUATED. THE INVESTIGATION CONCLUDED THAT THE LENGTH DISCREPANCY BETWEEN TRIAL AND IMPLANT WAS CAUSED BY AN OUT-OF-SPECIFICATION GMRS TRIAL EXTENSION PIECE. THE REPORTED EVENT REGARDING LENGTH DISCREPANCY BETWEEN TRIAL AND IMPLANT INVOLVING A GMRS TRIAL EXTENSION PIECE WAS CONFIRMED. THE CORRECTIVE ACTIONS WILL BE IDENTIFIED THROUGH NC (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TRIALS DID NOT MATCH IMPLANTS.

    Description of Event or Problem · 1

    TRIALS DID NOT MATCH IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134989 GMRS EXT TRIAL PIECE 40MM INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH TMP153

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other