BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIZE 4 ACCOLADE II 127 DEG

    MDR report key: 3852197 · Received June 5, 2014

    Report

    Report Number
    0002249697-2014-02141
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 18, 2014
    Report Date
    May 18, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K120578
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PERIPROSTHETIC FRACTURE INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION AND RESULTS COULD NOT BE PERFORMED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE HISTORY REVIEW INDICATED THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION BECAUSE THE HOSPITAL KEPT THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT FELL AND HAD PAIN. PATIENT HAD PERIPROSTHETIC FRACTURE IN RIGHT HIP. DOCTOR REDUCED FRACTURE WITH CERAMIC ACCOLADE, HE TOOK OUT STEM AND HEAD AND REPLACED WITH NEW ONES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT FELL AND HAD PAIN. PATIENT HAD PERIPROSTHETIC FRACTURE IN RIGHT HIP. DOCTOR REDUCED FRACTURE WITH CERAMIC ACCOLADE, HE TOOK OUT STEM AND HEAD AND REPLACED WITH NEW ONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329526 SIZE 4 ACCOLADE II 127 DEG IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 45993004

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| R