BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE PLUS TMZF HIP STEM #2

    MDR report key: 3895163 · Received June 25, 2014

    Report

    Report Number
    0002249697-2014-02433
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PSEUDOTUMOR AND CORROSION INVOLVING AN ACCOLADE PLUS TMZF HIP STEM #2 WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO DEVICE WAS RETURNED. A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED NO CERTAIN ROOT CAUSE OF FAILURE CAN BE ESTABLISHED FOR THIS CASE DUE TO LACK OF PROPER INFORMATION. A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. A COMPLAINT HISTORY REVIEW CONFIRMED NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE OF A LACK OF INFORMATION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH GROIN PAIN, APPROXIMATELY 6 YEARS AFTER HIP IMPLANTED. SCANS SHOWED PSEUDOTUMOR. REVISION OF RIGHT HIP, POSSIBLE PSEUDO TUMOR, TRUNNION SHOWED SIGNS OF POSSIBLE CORROSION. PSEUDOTUMOR EXCISED AND FEMORAL HEAD CHANGED. SURGEON CHOSE TO REMOVE COCR FEMORAL HEAD AND REPLACE WITH CERAMIC WITHOUT A SLEEVE. SURGEON IS AWARE THAT NOT USING A SLEEVE IS OFF LABEL.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH GROIN PAIN, APPROXIMATELY 6 YEARS AFTER HIP IMPLANTED. SCANS SHOWED PSEUDOTUMOR. REVISION OF RIGHT HIP, POSSIBLE PSEUDO TUMOR, TRUNNION SHOWED SIGNS OF POSSIBLE CORROSION. PSEUDOTUMOR EXCISED AND FEMORAL HEAD CHANGED. SURGEON CHOSE TO REMOVE COCR FEMORAL HEAD AND REPLACE WITH CERAMIC WITHOUT A SLEEVE. SURGEON IS AWARE THAT NOT USING A SLEEVE IS OFF LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372163 ACCOLADE PLUS TMZF HIP STEM #2 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 23492302

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R