BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRHK TIB INS 20MM XS/S S1/S2

    MDR report key: 23403728 · Received October 28, 2025

    Report

    Report Number
    0002249697-2025-01254
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    October 1, 2025
    Report Date
    October 28, 2025
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    UDI-DI
    07613327043839
    PMA / PMN Number
    K994207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: GMRS SMALL FEMORAL BUSHING; CAT # 64952105; LOT # LNE116. GMRS SMALL FEMORAL BUSHING; CAT # 64952105; LOT # LNK092. GMRS SMALL AXLE; CAT # 64952115; LOT # CTD138256. MRHK TIBIAL SLEEVE; CAT # 64812140; LOT # LNA419. MRHK BUMPER INSERT - NEUTRAL; CAT # 64812130; LOT # LNA054. MRH TIB ROT COMP XS-XL; CAT # 64812100; LOT # 220071. TRI CEMENTED STEM 12MMX50MM; CAT # 5560-S-112; LOT # 1155343M. GMRS DIST FEM COMP SML R 65MM; CAT # 64952020; LOT # Y4S3B. MRH TIB ROT COMP XS-XL; CAT # 64812100; LOT # 220027. MRH TIBIAL B/PLT KEEL SML 2; CAT # 64813111; LOT # RSR7P. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. REPORTED EVENT: AN EVENT REGARDING INFECTION INVOLVING A MRH INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE THE REPORTED DEVICE WAS MANUFACTURED WITH NO REPORTED RELEVANT DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENT FOR THE LOT OR STERILE LOT REFERENCED. CONCLUSIONS: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. ALL STRYKER PRODUCTS SOLD AS STERILE ARE VALIDATED TO A MINIMUM STERILITY ASSURANCE LEVEL SAL OF 10^-6 IN ACCORDANCE WITH APPLICABLE ISO STANDARDS. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS PATHOLOGY REPORTS, PRE- AND POST-OPERATIVE X-RAYS AND THE REVISION OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    RIGHT KNEE. PATIENT REVISED DUE TO INFECTION. REPLACED WITH A STATIC NAIL SPACER. NO OTHER INFORMATION AVAILABLE DUE TO THE HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790442 MRHK TIB INS 20MM XS/S S1/S2 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH LNH625 07613327043839

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention| H