BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER. FEMORAL STEM + 2 PMMA

    MDR report key: 3002664 · Received March 13, 2013

    Report

    Report Number
    0002249697-2013-00978
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 22, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K974054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A FRACTURE INVOLVING AN EXETER STEM WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION CONFIRMED THAT THE STEM BROKE APPROXIMATELY 64MM FROM THE STEM DISTAL TIP. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE FRACTURE SURFACE EXAMINED. MEDICAL RECORDS EVALUATION NOT PERFORMED AS NO MEDICAL RECORDS WERE RECEIVED. DEVICE HISTORY INDICATED THAT ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY INDICATED THAT THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS RECEIVED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE SURGEON REPORTED VIA THE SALES REP THAT THE PATIENT WAS REQUIRED TO UNDERGO A REVISION SURGERY DUE TO A FRACTURE OF THE EXETER STEM.

    Description of Event or Problem · 1

    THE SURGEON REPORTED VIA THE SALES REP THAT THE PATIENT WAS REQUIRED TO UNDERGO A REVISION SURGERY DUE TO A FRACTURE OF THE EXETER STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105397 EXETER. FEMORAL STEM + 2 PMMA IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH GV280033

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R