BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3191709 · Received June 26, 2013

    Report

    Report Number
    0002249697-2013-02082
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN 36MM TRIDENT ALUMINA INSERT. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS AN ACCOLADE #3 127 DEGREE FEMORAL STEM AND HAD A SQUEAKY HIP AND PAIN. THE DOCTOR EXHAUSTED ALL NON OPERATIVE OPTIONS FOR THE PAIN AND SQUEAK AND DECIDED TO GO IN AND REVISE. WENT IN AND TOOK OUT THE CERAMIC FEMORAL HEAD AND CERAMIC LINER. THE CERAMIC HEAD HAD BLACK RESIDUE AT THE TAPERED JUNCTION. PUT IN A POLY LINER AND A HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290408 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| O| R