BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRHK TIB INS 13MM M/L M2/L2

    MDR report key: 19089961 · Received April 11, 2024

    Report

    Report Number
    0002249697-2024-00579
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    March 21, 2024
    Report Date
    April 11, 2024
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    UDI-DI
    07613327043846
    PMA / PMN Number
    K994207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: DEVICE NAME#MRH KNEE FEM L RGT; CAT#64811131; LOT#RHH3S. DEVICE NAME#TRI CEMENTED STEM 12MMX50MM; CAT#5560-S-112; LOT#1164752K. DEVICE NAME#MRH TIBIAL B/PLT KEEL LRG 2; CAT#64813113; LOT#PLY6P. DEVICE NAME#TRI CEMENTED STEM 12MMX50MM; CAT#5560-S-112 ; LOT#1564991K. DEVICE NAME#TRIATHLON SYM CONE AUG SZ C; CAT#5549-A-130; LOT#RTLG1. DEVICE NAME#MRH HDP ASSEMBLY PACK; CAT#64812150; LOT#LLK149. DEVICE NAME#MRH TIB ROT COMP XS-XL; CAT#64812100; LOT#211494. DEVICE NAME#MRH AXLE; CAT#64812120; LOT#CTD89319. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. H3 OTHER TEXT : DEVICE NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 0

    THIS IS FOR AMPUTATION OF THE PATIENT'S RIGHT LEG ON (B)(6) 2024. AS REPORTED: "WE DID AN EXCHANGE OF MOVEABLE PARTS ON MARCH 7TH BECAUSE OF INFECTION AND THEY DID A FLAP. AS OF YESTERDAY THE AMPUTATED HIS LEG AND EVERYTHING IS REMOVED." REP CONFIRMED AMPUTATION WAS DUE TO ONGOING INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126256 MRHK TIB INS 13MM M/L M2/L2 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH LLX507 07613327043846

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention| H