BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CONSTRAINED LINER

    MDR report key: 6144922 · Received December 5, 2016

    Report

    Report Number
    0002249697-2016-03817
    Event Type
    Injury
    Date Received
    December 5, 2016
    Date of Event
    November 7, 2016
    Report Date
    November 7, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    SURGEON PERFORMED RIGHT HIP REPLACEMENT DUE TO LINER DISASSOCIATED FROM CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797214 UNKNOWN CONSTRAINED LINER HIP IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention