BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHELL IMPLANT

    MDR report key: 6895507 · Received September 26, 2017

    Report

    Report Number
    0002249697-2017-02839
    Event Type
    Injury
    Date Received
    September 26, 2017
    Date of Event
    March 9, 2017
    Report Date
    September 26, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    AS REPORTED IN MEDWATCH REPORT # MW5071350: LOOSENING OF ACETABULAR CUP AND FEMORAL HEAD WITH RESULTANT WEAR OF ACETABULAR CUP AND CERAMIC CUP LINER. ONGOING PAIN WITH DIFFICULTY AMBULATING SECONDARY TO THE PAIN. DEVICES REPORTED: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED (JDI). STRYKER ACETABULAR CUP WITH CERAMIC LINER AND FEMORAL HEAD. TRIDENT ACETABULAR SYSTEM. NOT ALL DEVICES WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673197 UNKNOWN SHELL IMPLANT HIP IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R