BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE PLUS TMZF HIP STEM #3

    MDR report key: 3002829 · Received March 13, 2013

    Report

    Report Number
    0002249697-2013-00986
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 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

    THE PATIENT IS (B)(6). AN EVENT REGARDING ALLEGED FRETTING INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW INDICATED ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED 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. FURTHER INFORMATION SUCH AS RETURN OF THE DEVICE, OPERATIVE REPORTS, X-RAYS AND PATIENT MEDICAL RECORDS WOULD BE HELPFUL IN INVESTIGATING THIS EVENT FURTHER.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION BECAUSE IT IS STILL IMPLANTED. 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 SURGEON REVISED PATIENT'S LEFT ACCOLADE TMZF HIP DUE TO CORROSION AND FRETTING AT THE MODULAR HEAD / NECK JUNCTION. SURGEON CLEANED CORROSION AND IMPLANTED A TITANIUM SLEEVE, A CERAMIC HEAD, AND REPLACED THE LINER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON REVISED PATIENT'S LEFT ACCOLADE TMZF HIP DUE TO CORROSION AND FRETTING AT THE MODULAR HEAD / NECK JUNCTION. SURGEON CLEANED CORROSION AND IMPLANTED A TITANIUM SLEEVE, A CERAMIC HEAD, AND REPLACED THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105574 ACCOLADE PLUS TMZF HIP STEM #3 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 30710403

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| O| R