BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CITATION TMZF HA STEM #7 LEFT

    MDR report key: 3875110 · Received June 16, 2014

    Report

    Report Number
    0002249697-2014-02282
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    September 20, 2013
    Report Date
    May 21, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K993768
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PERIPROSTHETIC FRACTURE INVOLVING A CITATION STEM WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS PERFORMED AND CONCLUDED: IN THIS ELDERLY, FEMALE A PERI-PROSTHETIC FRACTURE THROUGH POST-MENOPAUSAL OSTEOPOROTIC BONE REQUIRED OPEN REDUCTION/INTERNAL FIXATION AND REVISION OF THE FEMORAL STEM APPROXIMATELY TWO YEARS POST-IMPLANTATION. THERE IS NO EVIDENCE THAT THESE WELL-FIXED COMPONENTS IN THIS CASE WERE RESPONSIBLE FOR THIS CLINICAL SITUATION." DEVICE HISTORY REVIEW INDICATED ALL DEVICES 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. CONCLUSIONS: A MEDICAL REVIEW WAS PERFORMED AND THE EVENT WAS CONFIRMED. A MEDICAL REVIEW WAS PERFORMED BASED ON THE AVAILABLE INFORMATION AND CONCLUDED THAT THERE WAS NO EVIDENCE OF A DEVICE RELATED ISSUE. RETURN OF THE DEVICE IS HOWEVER NEEDED TO FULLY INVESTIGATE THE EVENT.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PERIPROSTHETIC FRACTURE OF LEFT HIP. REVISION OF LEFT FEMORAL COMPONENT TO A RESTORATION MODULAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PERIPROSTHETIC FRACTURE OF LEFT HIP. REVISION OF LEFT FEMORAL COMPONENT TO A RESTORATION MODULAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352434 CITATION TMZF HA STEM #7 LEFT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 36445301

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention