BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIZE 6 ACCOLADE II 127 DEG

    MDR report key: 4092447 · Received September 16, 2014

    Report

    Report Number
    0002249697-2014-03488
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K120578
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PERIPROSTHETIC FRACTURE INVOLVING AN ACCOLADE II STEM WAS REPORTED. THE EVENT WAS CONFIRMED. A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION INDICATED THAT. THE REVIEW OF THE PROVIDED INFORMATION BY A CLINICAL CONSULTANT CONFIRMED THE EVENT BUT COULD NOT DETERMINE A ROOT CAUSE. DEVICE HISTORY REVIEW. ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A POST OP FX AND REQUIRED REVISION SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A POST OP FX AND REQUIRED REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572912 SIZE 6 ACCOLADE II 127 DEG IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH 47509601

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention