BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    19MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006

    MDR report key: 2945095 · Received December 21, 2012

    Report

    Report Number
    9616680-2012-01471
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    K040734
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERNAL PACKAGING WAS PERFORATED FROM THE COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 19MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006 IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA 36605701

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other