BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4221387 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04101
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN BOLT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LEFT HIP REVISION DUE TO PERIPROSTHETIC FRACTURE, WHILE TWERKING, BOLT SNAPPED. SALES REP SAYS THAT PRIMARY PRODUCT WAS NOT STRYKER PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701448 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT KWY STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other