BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER

    MDR report key: 2093801 · Received May 11, 2011

    Report

    Report Number
    MW5020592
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 22, 2011
    Report Date
    May 11, 2011
    Manufacturer
    STRYKER -GLOBAL-
    Product Code
    MEH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH STRYKER ANATOMIC DUAL MOBILITY TOTAL HIP REPLACEMENT WAS NON-COMPLIANT WITH POSTOP INSTRUCTIONS AND BENT/TWISTED HIS HIP 1 WEEK AFTER HIP REPLACEMENT FOR A HIP FRACTURE, AND SUSTAINED A DISLOCATION. THE HIP WAS CLOSED REDUCED IN EMERGENCY ROOM, BUT THE PRODUCT FAILED BECAUSE, THE ALL POLYETHYLENE HIP BALL DISASSOCIATED FROM THE CERAMIC HIP BALL COMPONENT. THIS SHOULD NOT OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER ANATOMIC DUAL MOBILITY TOTAL HIP MEH STRYKER -GLOBAL- ADM

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other