BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE PLUS TMZF HIP STEM #4

    MDR report key: 4536073 · Received February 23, 2015

    Report

    Report Number
    0002249697-2015-00419
    Event Type
    Injury
    Date Received
    February 23, 2015
    Date of Event
    January 26, 2015
    Report Date
    January 26, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. -MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT INFORMATION WAS RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -DEVICE HISTORY REVIEW COULD NOT BE PERFORMED AS THE LOT ID IS UNKNOWN. -COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS THE LOT ID IS UNKNOWN. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS DEVICE RETURN, X-RAYS AND PATIENT MEDICAL RECORDS WOULD BE HELPFUL IN INVESTIGATING THIS EVENT FURTHER. IF ADDITIONAL INFORMATION AND/OR DEVICE BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS. NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    A REVISION OF RIGHT HIP WAS REPORTED DUE TO PERIPROSTHETIC FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125704 ACCOLADE PLUS TMZF HIP STEM #4 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention