BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER V40 STEM 44MM NO 0

    MDR report key: 3023939 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01128
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 8, 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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN 44 DEGREE OFFSET EXETER STEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED. THE EXETER STEM IS BROKEN THROUGH THE PREHENSION HOLE. THE FRACTURE IS INCOMPLETE, THE TWO PARTS ARE STILL ATTACHED TOGETHER. THERE ARE SCRATCHES ON THE STEM THAT MUST HAVE BEEN DONE DURING THE EXPLANTATION OF THE DEVICES. THERE ARE ALSO MARKS OF FRETTING CORROSION ON THE DISTAL PART OF THE STEM. THE MEDICAL REVIEW NOTED THAT THE ROOT CAUSE OF THIS EXETER STEM FRACTURE CAN NOT BE DETERMINED WITH LIMITED CLINICAL AND RADIOLOGICAL INFORMATION PROVIDED. DEVICE HISTORY REVIEW THE SPECIFIC LOT INDICATED THAT THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. A REVIEW OF THE COMPLAINT HISTORY DATABASE SHOWS THAT THERE HAVE BEEN NO SIMILAR REPORTED EVENTS FOR THE SUBJECT LOT CODE.

    Description of Event or Problem · 1

    THE SURGEON REPORTED TO THE SALES REP THAT HIS PATIENT'S EXETER STEM FRACTURED AND HE HAD TO REVISE THE IMPLANT. IT WAS REPORTED THAT THE STEM FRACTURED WHILST THE PATIENT WAS PLAYING GOLF.

    Description of Event or Problem · 1

    THE SURGEON REPORTED TO THE SALES REP THAT HIS PATIENT'S EXETER STEM FRACTURED AND HE HAD TO REVISE THE IMPLANT. IT WAS REPORTED THAT THE STEM FRACTURED WHILST THE PATIENT WAS PLAYING GOLF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126651 EXETER V40 STEM 44MM NO 0 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH G2953557

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R