BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT ALUMINA INSERT

    MDR report key: 3002824 · Received March 13, 2013

    Report

    Report Number
    0002249697-2013-00983
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MRA
    PMA / PMN Number
    P000013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE LIMITED INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING PROGRESS NOTES, IMAGING RESULTS, AND INFORMATION REGARDING THE NATURE, DURATION, AND LOCATION OF THE PAIN ARE NEEDED TO FULLY INVESTIGATE THE EVENT.

    Additional Manufacturer Narrative · 1

    THE OTHER DEVICE LISTED IN THIS REPORT IS A ALUMINA V40-FEMORAL HEAD, 32MM, -4MM NK, CAT # 6565-0-032, LOT # UNKNOWN. IT CANNOT BE DETERMINED WHICH, IF EITHER OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THE PATIENT KEPT THEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF THE LEFT HIP. PATIENT COMPLAINING OF PAIN AND FLUID COLLECTION. CERAMIC ON CERAMIC REMOVED; POLYETHYLENE LINER AND METAL HEAD IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF THE LEFT HIP. PATIENT COMPLAINING OF PAIN AND FLUID COLLECTION. CERAMIC ON CERAMIC REMOVED; POLYETHYLENE LINER AND METAL HEAD IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105751 TRIDENT ALUMINA INSERT IMPLANT MRA STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| O| R