BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRS FEM STEM W/O BODY 11X127MM

    MDR report key: 3875109 · Received June 16, 2014

    Report

    Report Number
    0002249697-2014-02290
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K040749
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING FEMORAL STEM LOOSENING INVOLVING AN MRS STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO ITEMS WERE RETURNED. MEDICAL EVALUATION NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. DEVICE HISTORY REVIEW THERE WERE NO REPORTED DISCREPANCIES FOR THE REFERENCED LOT. COMPLAINT HISTORY REVIEW. THERE WERE NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE DEVICE IS NOT RETURN, PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS KEPT BY THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A LOOSE GMR'S CEMENTED STEM. SO SURGEON HAD BIOMET MANUFACTURE A CUSTOM ADAPTOR TO JOIN A BIOMET COMPRESS FEMORAL IMPLANT WITH A GMR'S DISTAL FEMUR. SURGEON ELECTED TO PUT IN ALL NEW COMPONENTS WITH EXCEPTION OF THE TIBIAL BASEPLATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A LOOSE GMRS CEMENTED STEM. SO SURGEON HAD BIOMET MANUFACTURE A CUSTOM ADAPTOR TO JOIN A BIOMET COMPRESS FEMORAL IMPLANT WITH A GMRS DISTAL FEMUR. SURGEON ELECTED TO PUT IN ALL NEW COMPONENTS WITH EXCEPTION OF THE TIBIAL BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352212 MRS FEM STEM W/O BODY 11X127MM IMPLANT KRO STRYKER ORTHOPAEDICS-MAHWAH 101273G

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention