BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40 STEM 33MM

    MDR report key: 2902925 · Received November 29, 2012

    Report

    Report Number
    9616680-2012-01229
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 8, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    K011623
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE FOR IDENTIFICATION OR EVALUATION, HOWEVER, THE SALES REPRESENTATIVE WAS PRESENT AT THE SURGERY AND CONFIRMED THE EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT.

    Description of Event or Problem · 1

    WHEN THE BOX WAS OPENED, IT WAS FOUND THAT THE CENTRALIZER WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER V40 STEM 33MM IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA G3283317

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other