BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE PLUS TMZF HIP STEM #3

    MDR report key: 3781464 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01562
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    January 24, 2014
    Report Date
    April 7, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CORROSION INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION AND RESULTS. THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. THE REPORTED DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK. COMPLAINT HISTORY REVIEW. THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS FURTHER INFORMATION IS NEEDED NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    (MW5034909) IT WAS REPORTED THAT PAINFUL TOTAL HIP ARTHROPLASTY. THE PATIENT HAD A HISTORY OF INSTABILITY. ADVERSE TISSUE RESPONSE DUE TO TAPER CORROSION.

    Description of Event or Problem · 1

    (MW5034909) IT WAS REPORTED THAT PAINFUL TOTAL HIP ARTHROPLASTY. THE PATIENT HAD A HISTORY OF INSTABILITY. ADVERSE TISSUE RESPONSE DUE TO TAPER CORROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260913 ACCOLADE PLUS TMZF HIP STEM #3 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 24502606

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R