BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRHK TIB INS 16MM XS/S S1/S2

    MDR report key: 14951890 · Received July 7, 2022

    Report

    Report Number
    0002249697-2022-00982
    Event Type
    Injury
    Date Received
    July 7, 2022
    Date of Event
    June 14, 2022
    Report Date
    July 7, 2022
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    UDI-DI
    07613327043808
    PMA / PMN Number
    K994207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MRHK BUMPER INSERT 3 DEGREES; CAT# 64812133 ; LOT# LKS653; GMRS SMALL FEMORAL BUSHING; CAT# 64952105 ; LOT# LKX144; GMRS SMALL FEMORAL BUSHING; CAT# 64952105; LOT# LKX144; GMRS SMALL AXLE; CAT# 64952115; LOT# CTD59683; MRH TIB ROT COMP XS-XL; CAT# 64812100; LOT#180755; GMRS DIST FEM COMP SML L 65MM; CAT# 64952010; LOT#J4H2R; MRHK TIBIAL SLEEVE; CAT# 64812140; LOT# LKS093. 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 · 0

    DR. PERFORMED AN ABOVE THE KNEE AMPUTATION, LEFT SIDE OF A PATIENT THAT HAD A GMRS DISTAL FEMORAL REPLACEMENT IN DUE TO INFECTION. THE PREVIOUS SURGERY WAS ON (B)(6) 2022 FOR AN INFECTION, HOWEVER THE KNEE BECAME INFECTED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2103992 MRHK TIB INS 16MM XS/S S1/S2 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH 6481-3-216 LLC740 07613327043808

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Hospitalization| R