BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMRS DIST FEM COMP STD L 65MM

    MDR report key: 8621310 · Received May 17, 2019

    Report

    Report Number
    0002249697-2019-01983
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    January 10, 2019
    Report Date
    May 17, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    UDI-DI
    07613327049824
    PMA / PMN Number
    K023087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: 64813310, MRHK TIB INS 10MM M/L M2/L2, A9B9J. 64956100, GMRS EXTENSION PIECE 100MM, CP36T. 64813112, MRH TIBIAL B/PLT KEEL MED 2, CSH3A. 64853711, MRS CURVED FEM STEM 11 X 127MM, 163303A. 64786620, TI DUR REG FLUTED STEM 14X80MM, 48300. 64812140, MRHK TIBIAL SLEEVE, LGC967 . 64812120, MRH AXLE, CTD20757. 64812110, MRHK FEMORAL BUSHING, LHB047. 64812110, MRHK FEMORAL BUSHING, LHB196. 64812133, MRHK BUMPER INSERT 3 DEGREES, LGC197. 64812100, MRH TIB ROT COMP XS-XL, 116483. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Description of Event or Problem · 1

    THIS PI IS FOR SECOND DEBRIDEMENT. ON (B)(6) 2018, THE GMRS IMPLANT WAS INSERTED AFTER BEING DIAGNOSED WITH OSTEO SARCOMA AND THE TUMOR REMOVED. 4 MONTHS LATER, FOUND THAT THERE WAS AN INFECTION ON THE IMPLANT. THE IMPLANT WAS NOT REMOVED BUT DEBRIDEMENT WAS DONE. SINCE THE SURROUNDING MUSCLE AND TISSUES WERE HEALTHY NO FURTHER PROCEDURE WAS REQUIRED. AGAIN IN (B)(6) 2019 INFECTION OCCURRED AND A SECOND DEBRIDEMENT PROCEDURE WAS DONE. ANTIBIOTIC BEADS WERE USED. DURING THE SECOND TIME DEBRIDEMENT IT WAS FOUND THAT THE IMPLANT HAS MOVED FROM ITS IMPLANTED LOCATION AND IT IS CAUSING SEVERE UNBEARABLE PAIN. UPDATE 5/17/2019: PER COMMUNICATION WITH COMPANY REP, SUBJECT DEVICE WAS IDENTIFIED AS THE FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414706 GMRS DIST FEM COMP STD L 65MM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH CP36T 07613327049824

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R