BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRHK TIB INS 13MM M/L M2/L2

    MDR report key: 15307914 · Received August 28, 2022

    Report

    Report Number
    0002249697-2022-01254
    Event Type
    Injury
    Date Received
    August 28, 2022
    Date of Event
    October 12, 2021
    Report Date
    August 28, 2022
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    UDI-DI
    07613327043846
    PMA / PMN Number
    K994207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: GMRS DIST FEM COMP STD L 65MM; CAT# 64952030; LOT# LNS2D, TRI CEMENTED STEM 12MMX50MM; CAT# 5560-S-112; LOT# 0114814D, GMRS EXTENSION PIECE 40MM; CAT# 64956040; LOT# L7E2T, MRHK TIBIAL SLEEVE; CAT# 64812140; LOT# LKM984, MRH TIB ROT COMP XS-XL; CAT# 64812100; LOT# 179104A, MRH AXLE; CAT# 64812120; LOT# CTD62970, MRHK FEMORAL BUSHING; CAT# 64812110; LOT# LKM967, MRHK BUMPER INSERT 3 DEGREES; CAT# 64812133; LOT# LKT512, MRH TIBIAL B/PLT KEEL MED 2; CAT# 64813112; LOT# L3Y3A, TRIATHLON SYM CONE AUG SZ E; CAT# 5549-A-150; LOT# T1HY1, MRS FEM STEM W/O BODY 13X127MM; CAT# 64853113; LOT# 239029D. 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

    THE PATIENT HAD AN INDEX LEFT TKA OUTSIDE OF CORS SCOPE. THE PATIENT DEVELOPED PJI (PERIPROSTHETIC JOINT INFECTION) IN THE LEFT KNEE AND UNDERWENT REVISION WITH A GMRS SYSTEM FOR PJI WITH ALL COMPONENTS EXCHANGED ON SEPTEMBER 21ST, 2021 (THEN INCLUDED INTO CORS). THE PATIENT DEVELOPED AGAIN PJI AND WAS REVISED WITH FEMUR AND ALL ROTATING HINGE COMPONENTS EXCHANGED ON (B)(6), 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2392963 MRHK TIB INS 13MM M/L M2/L2 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH 6481-3-313 LKT060 07613327043846

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Hospitalization| R