BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRS SML FEM STEM 8 X 102MM

    MDR report key: 3081102 · Received April 26, 2013

    Report

    Report Number
    0002249697-2013-01456
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 5, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K040749
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING STEM FRACTURE INVOLVING AN MRS STEM WAS REPORTED. THE EVENT WAS CONFIRMED BASED ON THE PHOTOGRAPHS PROVIDED. BASED ON THE PHOTOGRAPHS OF THE EXPLANTED MRS STEM PROVIDED, THE STEM FRACTURED AT THE JUNCTION OF THE BODY AND THE 8MM STEM. DEVICE EVALUATION WAS NOT POSSIBLE AS THE DEVICE WAS NOT RETURNED TO STRYKER. THE CLINICIAN REVIEW OF THIS CASE INDICATED THAT THE CHOICE FOR CEMENTED FIXATION IN THIS CASE HAS REDUCED AVAILABLE IMPLANT DIAMETER FURTHER TO A LEVEL WHERE STRENGTH COULD NOT BE GUARANTEED FOR A LONG SERVICE LIFE. THERE IS NO EVIDENCE FOR PATIENT-RELATED FACTORS FURTHER CONTRIBUTING TO THE OVERLOAD CONDITION, THE PATIENT WAS LOWBODY-WEIGHT. ADDITIONALLY, THERE IS NO EVIDENCE FOR DEVICE-RELATED FACTORS PLAYING A ROLE IN THIS CASE EVEN THOUGH THERE IS NO EXPLANT MATERIALS ANALYSIS AVAILABLE TO CONFIRM SUCH. THIS PI CASE IS NOT DEVICE-RELATED. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE ROOT CAUSE OF THIS FAILURE IS PROCEDURE-RELATED.

    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

    PATIENT PRESENTED TO EMERGENCY WITH ANTERIOR THIGH PAIN AND SWELLING. GMRS DISTAL FEMORAL STEM BROKEN. REVISION OF DISTAL FEMORAL GMRS TO REPLACE STEM.

    Description of Event or Problem · 1

    PATIENT PRESENTED TO EMERGENCY WITH ANTERIOR THIGH PAIN AND SWELLING. GMRS DISTAL FEMORAL STEM BROKEN. REVISION OF DISTAL FEMORAL GMRS TO REPLACE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181992 MRS SML FEM STEM 8 X 102MM IMPLANT KRO STRYKER ORTHOPAEDICS-MAHWAH TEC711A

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention