BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40 STEM 44MM NO 0

    MDR report key: 2143512 · Received June 2, 2011

    Report

    Report Number
    9616680-2011-00370
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 18, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    K891454
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADD'L INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE SURGEON WAS PICKING UP THE LIFT TAB, IT TORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER V40 STEM 44MM NO 0 IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA G3006741

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other