BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CC TIBIAL INSERT SZ 4, 18MM

    MDR report key: 15535790 · Received October 4, 2022

    Report

    Report Number
    1038671-2022-01225
    Event Type
    Injury
    Date Received
    October 4, 2022
    Date of Event
    July 30, 2019
    Report Date
    March 5, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862054364
    PMA / PMN Number
    K954208
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. CONCOMITANT DEVICE(S): 200-02-35 - THREE PEG PATELLA 35MM, 1658017. 204-34-08 - FLUTED STEM EXTENSION 80L X 14 MM, 1674713. 204-40-12 - STEM EXTENSION W/SLOT 120L X20 MM, 1051537. 204-63-05 - TIBIAL AUGMENT BLOCK 1/2-SZ 3 5MM, 1885241, 1885243. 208-01-04 - CC FEMORAL SZ 4, 8581248. 208-04-42 - TRAP TRAY, OFFSET BETA CEM., SZ 4F/3T, 1706938. 208-04-76 - SCREW, OFFSET, SZHH, 1153926. 208-06-04 - CC DISTAL FEM AUGMENT SZ 4, 10MM, 1351851, 1931859. 208-07-04 - CC POSTERIOR FEM AUGMENT SZ 4, 5MM, 1813897. 208-09-05 - CC STEM EXT ADAPTOR 5 DEGREE, 2066882.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL THAT A MALE PATIENT HAD RIGHT KNEE REPLACEMENT INDEX SURGERY ON (B)(6) 2011 AND A REVISION SURGERY ON (B)(6) 2019 APPROXIMATELY 8 YEARS AFTER IMPLANT. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588112 CC TIBIAL INSERT SZ 4, 18MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 208-24-18 UNK 10885862054364

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention