BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN 32MM LINER

    MDR report key: 5683066 · Received May 26, 2016

    Report

    Report Number
    0002249697-2016-01741
    Event Type
    Injury
    Date Received
    May 26, 2016
    Date of Event
    May 2, 2016
    Report Date
    May 2, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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.

    Description of Event or Problem · 1

    REVISION OF LINER. SALES REP REPORTING WAS NOT PRESENT FOR THE CASE. PRODUCTS EXPLANTED IS 06-3299 LOT: 20027101 AND A LINER. THE LINER (32MM LINER FOR A 54MM CUP) WAS DESTROYED BEYOND RECOGNITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337885 UNKNOWN 32MM LINER HIP IMPLANT KWY STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention