BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRH KNEE FEM S RGT

    MDR report key: 3941297 · Received July 17, 2014

    Report

    Report Number
    0002249697-2014-02783
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K002552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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. NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION SURGERY DUE TO FRACTURE OF AN MRH FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION WAS PERFORMED AS PART OF THE MATERIAL ANALYSIS REPORT (MAR). THE RETURNED DEVICE IS FRACTURED THROUGH THE LATERAL CONDYLE. MAR INDICATED THAT FATIGUE STRIATIONS WERE PRESENT AT MANY LOCATIONS OF THE FRACTURE SURFACE INDICATING THAT THE FRACTURE PROGRESSED IN FATIGUE. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE FEATURES EXAMINED -MEDICAL RECORDS RECEIVED AND EVALUATION: CLINCIAN REVIEW OF THE MEDICAL RECORDS INDICATED: IN THIS LONG-TERM FOLLOW-UP OF ONCOLOGIC SALVAGE SURGERY IN A YOUNG, ACTIVE PATIENT, FATIGUE FRACTURE OF THE SEMICONSTRAINED COMPONENT IS NOT UNEXPECTED. -DEVICE HISTORY REVIEW: REVIEW OF THE DHR WAS SATISFACTORY. -COMPLAINT HISTORY REVIEW: THERE WERE NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE REPORTED EVENT REGARDING A FRACTURE OF THE FEMORAL COMPONENT IS CONFIRMED. MATERIAL ANALYSIS INDICATED THAT FATIGUE STRIATIONS WERE PRESENT AT MANY LOCATIONS OF THE FRACTURE SURFACE INDICATING THAT THE FRACTURE PROGRESSED IN FATIGUE. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE FEATURES EXAMINED. CLINCIAN REVIEW OF THE MEDICAL RECORDS INDICATED: IN THIS LONG-TERM FOLLOW-UP OF ONCOLOGIC SALVAGE SURGERY IN A YOUNG, ACTIVE PATIENT, FATIGUE FRACTURE OF THE SEMICONSTRAINED COMPONENT IS NOT UNEXPECTED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH A MRH/GMRS PROXIMAL TIBIA UNSTABLE PROSTHESIS. IT WAS ASSUMED TO BE A WORN SET OF BUSHINGS. UPON OPENING THE KNEE IT WAS DETERMINED THAT THE PROBLEM WAS NOT A SET OF WORN BUSHINGS BUT RATHER A FRACTURED MRH SMALL FEMORAL COMPONENT. THE LATERAL CONDYLE OF THE FEMORAL COMPONENT HAD FRACTURED OFF. A NEW MRH SMALL FEMORAL COMPONENT WAS CEMENTED IN PLACE ALONG WITH ALL NEW CORRESPONDING PARTS.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH A MRH/GMRS PROXIMAL TIBIA UNSTABLE PROSTHESIS. IT WAS ASSUMED TO BE A WORN SET OF BUSHINGS. UPON OPENING THE KNEE IT WAS DETERMINED THAT THE PROBLEM WAS NOT A SET OF WORN BUSHINGS BUT RATHER A FRACTURED MRH SMALL FEMORAL COMPONENT. THE LATERAL CONDYLE OF THE FEMORAL COMPONENT HAD FRACTURED OFF. A NEW MRH SMALL FEMORAL COMPONENT WAS CEMENTED IN PLACE ALONG WITH ALL NEW CORRESPONDING PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418449 MRH KNEE FEM S RGT IMPLANT KRO STRYKER ORTHOPAEDICS-MAHWAH LKUFH-2

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| O| R