BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER ORTHOPAEDICS

    MDR report key: 755374 · Received August 11, 2006

    Report

    Report Number
    MW1040033
    Event Type
    Injury
    Date Received
    August 11, 2006
    Date of Event
    March 27, 2006
    Report Date
    August 11, 2006
    Manufacturer
    STRYKER
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT HAD THE CERAMIC BALL PORTION OF A STRYKER HIP REPLACEMENT UNIT "EXPLODE" AFTER INSTALLMENT, RESULTING IN THE NEED FOR SURGICAL REPLACEMENT OF THE DAMAGED UNIT. THE DAMAGED UNIT IS AVAILABLE FOR INSPECTION AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER ORTHOPAEDICS TRIDENT CERAMIC HIP REPLACEMENT SYSTEM LZO STRYKER * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| O| S