BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3882084 · Received June 18, 2014

    Report

    Report Number
    0002249697-2014-02363
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN 16MM DURACON A/P LIPPED LINER. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS THE PATIENT REQUESTED TO KEEP IT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POLY WORE OUT AND THE BASEPLATE WAS LOOSE. PHYSICIAN REPLACED BASEPLATE AND POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358563 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT KWA STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention