BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMRS TRL PROX FEM COMP STD

    MDR report key: 3030340 · Received April 2, 2013

    Report

    Report Number
    0002249697-2013-01164
    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

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

    Additional Manufacturer Narrative · 1

    THERE WERE NO REPORTED DISCREPANCIES AND THERE WERE NO OTHER EVENTS FOR THE REFERENCED LOT FOR THE RELATED ISSUE. THE REPORTED LENGTH DISCREPANCY BETWEEN TRIAL AND IMPLANT COMPONENTS ONLY CONCERNS THE TRIAL EXTENSION PIECES. THERE IS NO ALLEGATION OR EVIDENCE THAT THERE IS A LENGTH DISCREPANCY BETWEEN THE GMRS TRIAL PROXIMAL FEMORAL COMPONENT AND ITS CORRESPONDING IMPLANT COMPONENT. BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT. THE REPORTED EVENT REGARDING LENGTH DISCREPANCY BETWEEN TRIAL AND IMPLANT INVOLVING A GMRS TRIAL PROXIMAL FEMORAL COMPONENT WAS REPORTED.

    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
    133764 GMRS TRL PROX FEM COMP STD INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH LXSBK1

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other