BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIZE 6 ACCOLADE II 127 DEG

    MDR report key: 3181289 · Received June 21, 2013

    Report

    Report Number
    0002249697-2013-02003
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K120578
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT EXPLANT DATE UPDATED. AN EVENT REGARDING INTRA-OPERATIVE PERIPROSTHETIC FRACTURE INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION COULD NOT BE PERFORMED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE PROVIDED X-RAYS BY A CLINICAL CONSULTANT INDICATED: "X-RAYS CONFIRMED PERI-PROSTHETIC FRACTURE WAS TREATED. DEVICE HISTORY REVIEW INDICATED THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW 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 PROVIDED.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE WAS NOT RETAINED AND IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS EVENT WAS DISCOVERED DURING A MONITOR VISIT FOR THE TRITANIUM PRIMARY STUDY. THE SUBJECT UNDERWENT THE SURGERY ON (B)(6) 2013. DURING THE SURGERY, THE SUBJECT EXPERIENCED A PERIPROSTHETIC FEMORAL FRACTURE WHILE THE ACCOLADE II STEM WAS BEING IMPLANTED. THE SURGEON IMPLANTED THE RESTORATION MODULAR STEM AS THIS STEM WAS BETTER SUITED FOR THE SUBJECT AND USED CIRCLAGE CABLES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS EVENT WAS DISCOVERED DURING A MONITOR VISIT FOR THE TRITANIUM PRIMARY STUDY. THE SUBJECT UNDERWENT THE SURGERY ON (B)(6) 2013. DURING THE SURGERY, THE SUBJECT EXPERIENCED A PERIPROSTHETIC FEMORAL FRACTURE WHILE THE ACCOLADE II STEM WAS BEING IMPLANTED. THE SURGEON IMPLANTED THE RESTORATION MODULAR STEM AS THIS STEM WAS BETTER SUITED FOR THE SUBJECT AND USED CIRCLAGE CABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282891 SIZE 6 ACCOLADE II 127 DEG IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 42655103

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other