BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODIFIED ACE.INSERT 28MMX46MM

    MDR report key: 3781256 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01639
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    COMPONENTS WERE REVISED DUE TO POLY WEAR AND FRACTURE OF POLY. REVISION SURGERY ON HER RIGHT HIP TO PLACE A NEW CUP, LINER, AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259271 MODIFIED ACE.INSERT 28MMX46MM IMPLANT KWY STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention