BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMRS DIST FEM COMP STD L 65MM

    MDR report key: 4416591 · Received January 14, 2015

    Report

    Report Number
    0002249697-2015-00077
    Event Type
    Injury
    Date Received
    January 14, 2015
    Date of Event
    December 18, 2014
    Report Date
    December 18, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K023087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING FEMORAL STEM LOOSENING INVOLVING A GMRS DISTAL FEMORAL COMPONENT WAS REPORTED. CONCLUSION: BASED ON THE LIMITED INFORMATION PROVIDED, IT IS UNLIKELY THAT THE DISTAL FEMORAL COMPONENT ITSELF WAS LOOSE AS IT IS PART OF A FEMORAL CONSTRUCT BUILT UP WITH THE FEMORAL MODULAR STEM AND IN THIS CASE WITH AN EXTENSION PIECE PLACED BETWEEN THE STEM AND THE DISTAL FEMORAL COMPONENT. THESE THREE DEVICES ARE LOCKED TOGETHER BY LOCKING TAPERS AND MAKE UP THE FEMORAL CONSTRUCT. THE EVENT DESCRIPTION INDICATES LOOSENING OF THE STEM WITHIN THE FEMORAL BONE AND THERE IS NO INDICATION OR ALLEGATION THAT THERE WAS A LOOSENING BETWEEN THE LOCKING TAPERS OF ANY OF THE THREE DEVICES. BOTH THE DISTAL FEMORAL COMPONENT AND THE EXTENSION PIECE WERE REVISED, MOST LIKELY AS A PRECAUTIONARY MEASURE AS IT IS LIKELY THAT THEY GET DAMAGED DURING THE DISASSEMBLY PROCESS. BASED ON THE PROVIDED INFORMATION, THERE IS NO INDICATION OR ALLEGATION THAT THE PRODUCT REPORTED IN THIS INVESTIGATION CONTRIBUTED TO THE FEMORAL STEM LOOSENING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. PATIENT RETAINED DEVICE.

    Description of Event or Problem · 1

    PATIENTS GMR'S DISTAL FEMORAL PROSTHESIS WAS REVISED FOR PAIN AND LOOSENING. FEMORAL IMPLANTS WERE GROSSLY LOOSE AND WERE REMOVED, MRH TIBIAL COMPONENT WAS WELL FIXED AND RETAINED. IMPLANT WAS REPLACED WITH ANOTHER GMRS LEFT STANDARD DISTAL FEMUR, 30MM EXTENSION PIECE, AND A LARGER 15MM CEMENTED STEM.

    Description of Event or Problem · 1

    PATIENT'S GMRS DISTAL FEMORAL PROSTHESIS WAS REVISED FOR PAIN AND LOOSENING. FEMORAL IMPLANTS WERE GROSSLY LOOSE AND WERE REMOVED, MRH TIBIAL COMPONENT WAS WELL FIXED AND RETAINED. IMPLANT WAS REPLACED WITH ANOTHER GMRS LEFT STANDARD DISTAL FEMUR, 30MM EXTENSION PIECE, AND A LARGER 15MM CEMENTED STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31641 GMRS DIST FEM COMP STD L 65MM IMPLANT KRO STRYKER ORTHOPAEDICS-MAHWAH SR8ET

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R