BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CITATION TMZF HA STEM #3 RIGHT

    MDR report key: 3852057 · Received June 5, 2014

    Report

    Report Number
    0002249697-2014-02118
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    February 3, 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 AND RESULTS 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, POST-MENOPAUSAL FEMALE TWO PERI-PROSTHETIC FRACTURES OCCURRED AFTER A FALL REQUIRING OPEN REDUCTION/INTERNAL FIXATION AND FEMORAL STEM REVISION TWELVE DAYS AFTER THE PRIMARY HIP ARTHROPLASTY SURGERY AND BEFORE FIRM BIOLOGIC FIXATION COULD OCCUR. THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS 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. 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

    MEDICAL RECORDS AND X-RAYS HAVE BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PERIPROSTHETIC FRACTURE DUE TO FALL. REMOVAL OF PRIMARY STEM, RECONSTRUCTION, REDUCTION AND FIXATION OF 2 FRACTURES WITH DALL MILES CABLES AND CONVERSION TO RESTORATION MODULAR HIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PERIPROSTHETIC FRACTURE DUE TO FALL. REMOVAL OF PRIMARY STEM, RECONSTRUCTION, REDUCTION AND FIXATION OF 2 FRACTURES WITH DALL MILES CABLES AND CONVERSION TO RESTORATION MODULAR HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329493 CITATION TMZF HA STEM #3 RIGHT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 41234502

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R