BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE 132 SIZE 2.5

    MDR report key: 3002690 · Received March 13, 2013

    Report

    Report Number
    0002249697-2013-00976
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICIAN REVIEW WAS NOT PERFORMED AS NO PATIENT MEDICAL RECORDS WERE PROVIDED FOR EVALUATION. DEVICE HISTORY REVIEW COULD NOT BE PERFORMED AS A VALID LOT ID WAS NOT PROVIDED. COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS A LOT ID WAS NOT PROVIDED. THE EVENT WAS NOT CONFIRMED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STEM, LINER, AND HEAD WERE REMOVED DUE TO PERI-PROSTHETIC FRACTURE OF THE RIGHT HIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STEM, LINER, AND HEAD WERE REMOVED DUE TO PERI-PROSTHETIC FRACTURE OF THE RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105453 ACCOLADE 132 SIZE 2.5 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| O| R