BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRHK TIB INS 16MM MD/LG M2/L2

    MDR report key: 17103256 · Received June 12, 2023

    Report

    Report Number
    0002249697-2023-00657
    Event Type
    Injury
    Date Received
    June 12, 2023
    Date of Event
    May 19, 2023
    Report Date
    June 12, 2023
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    UDI-DI
    07613327043853
    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

    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 DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS 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 RETURN OF THE DEVICE, PATHOLOGY REPORTS, PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY 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. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: DEVICE NAME#MRHK TIBIAL SLEEVE; CAT#64812140; LOT# LJX633. DEVICE NAME#MRHK BUMPER INSERT - NEUTRAL; CAT#64812130; LOT#LLC295. DEVICE NAME#MRHK FEMORAL BUSHING; CAT#64812110; LOT#LKT618. DEVICE NAME#MRHK FEMORAL BUSHING; CAT# 64812110; LOT#LKT618. DEVICE NAME#MRH KNEE FEM L RGT; CAT#64811131; LOT#LNP2D. DEVICE NAME#TI DUR REG FLUTED STEM18X155MM; CAT#64786725; LOT#113809. DEVICE NAME#MRHK FEM DISTAL BLK 10MM L; CAT#64811230; LOT#LJN4C. DEVICE NAME#MRH TIBIAL B/PLT KEEL MED 2; CAT#64813112; LOT#NBB7H. DEVICE NAME#TI DUR REG FLUTED STEM 16X80MM; CAT# 64786630; LOT#90235. DEVICE NAME#TRIATHLONASYMCONEAUGSZ C RM/LL; CAT#5549-A-232; LOT#H13N. DEVICE NAME#MRH TIB ROT COMP XS-XL; CAT#64812100; LOT#186034. DEVICE NAME#MRH AXLE; CAT#64812120;LOT# CTD77391. 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

    IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED: "THIS PT. HAS BEEN REVISED AND ¿WASHED OUT¿ MULTIPLE TIMES DUE TO WOUND-HEALING ISSUES. HE RECEIVED A ¿WASHOUT¿ AND COMPONENT-SWAP, ALONG WITH THE PLACEMENT OF ANTIBIOTIC BEADS MADE FROM SIMPLEX CEMENT AND ANTIBIOTICS. REQUIRES ANOTHER REVISION. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES." SPOKE TO REP. SURGEON SUSPECTS INFECTION AS THE PATIENT'S WOUND IS NOT HEALING (REPORTED CAUSE IS THAT THE PATIENT CONTINUES TO SMOKE AGAINST MEDICAL ADVICE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1468888 MRHK TIB INS 16MM MD/LG M2/L2 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH 6481-3-316 LLD605 07613327043853

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention| H