BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRS P/C PROX FEMUR W/TRUNNION

    MDR report key: 3023789 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01099
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K952970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: DEVICE MANUFACTURE DATE. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    REMOVED AN 18 YEAR OLD MRS CEMENTED PROXIMAL FEMUR. THE STEM WAS GROSSLY LOOSE IN THE FEMUR. SURGEON OSTEOTOMIZED THE FEMUR BELOW THE LUCENCY AND A NEW GMRS PROXIMAL FEMUR WAS CEMENTED IN.

    Description of Event or Problem · 1

    REMOVED AN (B)(6) YEAR OLD MRS CEMENTED PROXIMAL FEMUR. THE STEM WAS GROSSLY LOOSE IN THE FEMUR. SURGEON OSTEOTOMIZED THE FEMUR BELOW THE LUCENCY AND A NEW GMRS PROXIMAL FEMUR WAS CEMENTED IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125359 MRS P/C PROX FEMUR W/TRUNNION IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH S3TTA1

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention