BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE PLUS TMZF HIP STEM #4

    MDR report key: 3902724 · Received June 30, 2014

    Report

    Report Number
    0002249697-2014-02478
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    March 8, 2007
    Report Date
    June 26, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT 625-0T-32F TRIDENT ALUMINA INSERT, LOT CODE 11054502; CAT 17-3205E ALUMINA C-TAPER HEAD 32MM/+5, LOT CODE 11524701; CAT 542-11-54F TRIDENT PSL HA CLUSTER 54MM, LOT CODE 23602001; CAT 2030-6520-1 6.5 CANCELLOUS BONESCREW 20MM, LOT CODE 23870705. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE THAT RESULTED IN REVISION. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING REVISION INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: THE REPORTED DEVICE WAS ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW NOT PERFORMED AS A REASON FOR REVISION WAS NOT PROVIDED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS FURTHER INFORMATION SUCH AS PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS FOUND THROUGH IMPLANT SHEETS THAT THERE WAS A REVISION OF STRYKER HIP FOR UNKNOWN REASONS.

    Description of Event or Problem · 1

    IT WAS FOUND THROUGH IMPLANT SHEETS THAT THERE WAS A REVISION OF STRYKER HIP FOR UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379024 ACCOLADE PLUS TMZF HIP STEM #4 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 10925806

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention