BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER V40 STEM 44MM NO 0

    MDR report key: 3023941 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01130
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K011623
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS NOT CONFIRMED AS NO ITEMS WERE RETURNED PER HOSPITAL POLICY. MEDICAL RECORDS RECEIVED AND EVALUATION: X-RAYS CONFIRM ADEQUATE POSITION AND FIXATION OF COMPONENTS [¿]THERE IS NO CLEAR EVIDENCE TO ASSUME THAT EITHER PATIENT-RELATED OR PROCEDURE-RELATED FACTORS HAVE CONTRIBUTED TO AN OVERLOAD CONDITION IN THE PROXIMAL STEM SECTION RESULTING IN A FRACTURE OF THE NECK SOME 12-YEARS AFTER IMPLANTATION. ALL-IN-ALL, THE ROOT CAUSE OF THIS EXETER STEM FRACTURE CAN NOT BE DETERMINED WITH THE CURRENT INFORMATION WHERE WE SHOULD REALISE THAT BOTH THE CLINICAL AND RADIOLOGICAL INFORMATION ARE FAIRLY LIMITED AND NO EXPLANT MATERIALS ANALYSIS WAS PERFORMED. DEVICE HISTORY REVIEW: THERE HAVE BEEN NO REPORTED DISCREPANCIES FOR THE REPORTED LOT. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE ANALYSIS OF THE EXPLANTED DEVICE AND MEDICAL RECORDS ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    AN EXETER STEM INSERTED IN 2001 APPEARS TO HAVE BROKEN AT THE NECK WHIST IN A PATIENT. THE SURGEON REPORTS A PATIENT HISTORY OF SPONTANEOUS STEM FRACTURE ON (B)(6) 2013 WHILST WALKING. PATIENT UNDERWENT REVISION SURGERY.

    Description of Event or Problem · 1

    AN EXETER STEM INSERTED IN 2001 APPEARS TO HAVE BROKEN AT THE NECK WHIST IN A PATIENT. THE SURGEON REPORTS A PATIENT HISTORY OF SPONTANEOUS STEM FRACTURE ON (B)(6) 2013 WHILST WALKING. PATIENT UNDERWENT REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125798 EXETER V40 STEM 44MM NO 0 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH GA657062C6301

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| O| R