BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIZE 3 ACCOLADE II 127 DEG

    MDR report key: 3092405 · Received May 3, 2013

    Report

    Report Number
    0002249697-2013-01531
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K120578
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ALTR INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION COULD NOT 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 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.

    Description of Event or Problem · 1

    PATIENT HAD ADVERSE LOCAL TISSUE REACTION. DR (B)(6) REVISED PATIENT'S LEFT HIP. 36 C-TAPER BIOLOX HEAD AND V40 TO C-TAPER ADAPTER.

    Description of Event or Problem · 1

    PATIENT HAD ADVERSE LOCAL TISSUE REACTION. DR. (B)(6) REVISED PATIENT'S LEFT HIP. 36 C-TAPER BIOLOX HEAD AND V40 TO C-TAPER ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195352 SIZE 3 ACCOLADE II 127 DEG IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 36698705

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other