BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CITATION TMZF HA STEM #5 RIGHT

    MDR report key: 3875054 · Received June 16, 2014

    Report

    Report Number
    0002249697-2014-02281
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    August 23, 2012
    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 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.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING PERIPROSTHETIC FRACTURE INVOLVING A CITATION STEM WAS REPORTED. THE EVENT WAS CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW INDICATED: " X-RAY COPIES, ALL UNDATED, INCLUDE AN AP OF THE PELVIS AND AN AP AND LATERAL OF THE RIGHT HIP DEMONSTRATING AN UNCEMENTED RIGHT TOTAL HIP ARTHROPLASTY WITH NO SCREWS IN THE ACETABULUM. THE HIP IS REDUCED AND THE COMPONENTS ARE IN NOMINAL POSITION. AN AP OF THE PELVIS DEMONSTRATES A PERIPROSTHETIC FRACTURE OF THE RIGHT FEMUR WITH THE MEDIAL 3-CENTIMETER DISTAL TO THE LESSER TROCHANTER EXTENDING LATERALLY TO THE GREATER TROCHANTER. ANOTHER AP OF THE PELVIS AND AP AND LATERAL OF THE RIGHT HIP SHOWS NO CHANGE IN THE ACETABULUM, BUT NOW A RESTORATION MODULAR STEM WITH A LARGE LATERAL DALL-MILES CABLE HOOK PLATE WITH FIVE CERCLAGE CABLES IS NOTED. THE HIP AND FRACTURE ARE REDUCED AND ALL COMPONENTS ARE IN NOMINAL POSITION." THE CLINICIAN CONCLUDED: "THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING OR MATERIALS WERE RESPONSIBLE FOR THIS CLINICAL SITUATION." DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PERIPROSTHETIC FRACTURE. THERE WAS A REVISION OF THE CEMENTLESS THA TO RESTORATION MODULAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PERIPROSTHETIC FRACTURE. THERE WAS A REVISION OF THE CEMENTLESS THA TO RESTORATION MODULAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353359 CITATION TMZF HA STEM #5 RIGHT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 33937401

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention