BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRHK TIB INS 13MM XS/S S1/S2

    MDR report key: 15307915 · Received August 28, 2022

    Report

    Report Number
    0002249697-2022-01255
    Event Type
    Injury
    Date Received
    August 28, 2022
    Date of Event
    December 7, 2021
    Report Date
    August 28, 2022
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    UDI-DI
    07613327043792
    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: MRHK TIB INS 13MM XS/S S1/S2; 64813213; LKY021. MRH AXLE; 64812120; CTD59714. MRHK FEMORAL BUSHING; 64812110; LKN224. MRHK TIBIAL SLEEVE; 64812140; LKM996. MRHK BUMPER INSERT 3 DEGREES; 64812133; LKX417. MRH TIB ROT COMP XS-XL; 64812100; 180637. MRHK FEMORAL BUSHING; 64812110; LKN240. MRH KNEE FEM XS LFT; 64811100; JHA6B. MRH TIBIAL B/PLT KEEL SML 1; 64813110; L6H6T. TRIATHLONCTRFEMCONEAUG SZ1&2L; 5549-A-621; LH641. TRIATHLON SYM CONE AUG SZ C; 5549-A-130; T1J51. TRI PRESS-FIT STEM 14MM X 100MM; 5565-S-014; 0113782K. TRI PRESS-FIT STEM 16X150MM; 5566-S-016; 0087321D. MRHK FEM DISTAL BLK 10MM XS; 64811200; JEE4R. MRHK FEM DISTAL BLK 10MM XS; 64811200; JEE4R. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. NOT RETURNED.

    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 (B)(6) 2021 (THEN INCLUDED INTO CORS). THE PATIENT DEVELOPED AGAIN PJI AND WAS REVISED ONLY FOR ALL ROTATING HINGE COMPONENTS EXCHANGED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2392964 MRHK TIB INS 13MM XS/S S1/S2 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH 6481-3-213 LKY021 07613327043792

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention| H