BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CITATION TMZF HA STEM #7 LEFT

    MDR report key: 3852098 · Received June 5, 2014

    Report

    Report Number
    0002249697-2014-02119
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    March 12, 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 TMZF HA STEM #7 LEFT WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION AND RESULTS NOT PERFORMED AS NO ITEMS WERE RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS AND X-RAYS BY A CLINICAL CONSULTANT CONCLUDED: [¿] ¿THE PERIPROSTHETIC FRACTURE REQUIRING OPEN REDUCTION AND REVISION ONE WEEK POST-SURGERY WAS LIKELY THE RESULT OF AN UNRECOGNIZED UNDISPLACED INTRAOPERATIVE FEMORAL FRACTURE WHICH PROGRESSED POST-OPERATIVE BEFORE INGROWTH 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 ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW INDICATED THERE ARE NO OTHER EVENTS FOR THE LOT REFERENCED. THE INVESTIGATION CONCLUDED AS PER CLINICAL CONSULTANT¿S MEDICAL REVIEW THAT THE PERIPROSTHETIC FRACTURE REQUIRING OPEN REDUCTION AND REVISION ONE WEEK POST-SURGERY WAS LIKELY THE RESULT OF AN UNRECOGNIZED UNDISPLACED INTRAOPERATIVE FEMORAL FRACTURE WHICH PROGRESSED POST-OPERATIVE BEFORE INGROWTH COULD OCCUR. THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS WERE RESPONSIBLE FOR THIS CLINICAL SITUATION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS AND X-RAYS HAVE BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PERIPROSTHETIC FRACTURE. LEFT HIP REVISION WITH ASSOCIATED OPEN REDUCTION AND INTERNAL FIXATION OF FEMUR. CONVERSION OF FEMORAL COMPONENT TO RESTORATION MODULAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PERIPROSTHETIC FRACTURE. LEFT HIP REVISION WITH ASSOCIATED OPEN REDUCTION AND INTERNAL FIXATION OF FEMUR. CONVERSION OF FEMORAL COMPONENT TO RESTORATION MODULAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329832 CITATION TMZF HA STEM #7 LEFT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 31821101

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R