BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CC TIBIAL INSERT SZ 1D, 15MM

    MDR report key: 18759907 · Received February 22, 2024

    Report

    Report Number
    1038671-2024-00297
    Event Type
    Injury
    Date Received
    February 22, 2024
    Date of Event
    January 26, 2024
    Report Date
    July 29, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862054517
    PMA / PMN Number
    K011976
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10: CONCOMITANT PRODUCTS: THREE PEG PATELLA 29MM (CAT# 200-02-29 / SERIAL# (B)(6). CEMENTED TRAP TIB TRAY SZ 1DF/1T (CAT# 204-06-11 / SERIAL# (B)(6). STEM EXTENSION 120L X10 MM (CAT# 204-30-12 / SERIAL# (B)(6). STEM EXTENSION 120L X12 MM (CAT# 204-32-12 / SERIAL# (B)(6). CC FEMORAL SZ 1D, 1 (CAT# 208-01-01 / SERIAL# (B)(6). CC DISTAL FEM AUGMENT SZ 1, 5MM (CAT# 208-05-01 / SERIAL# (B)(6). CC DISTAL FEM AUGMENT SZ 1, 5MM (CAT# 208-05-01 / SERIAL# (B)(6). CC STEM EXT ADAPTOR 2 DEGREE (CAT# 208-09-02 / SERIAL# (B)(6) . ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REPORTED REVISION CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL, WEAR, LOOSENING, INFECTION, FRACTURE, INSTABILITY, AND/OR PATIENT RELATED FACTORS. POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RELEVANT CLINICAL INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY TEN YEARS POST INITIAL TKA, THE PATIENT HAD A POLYETHYLENE EXCHANGED ON AN OPTETRAK CC KNEE. IMAGES AND X-RAYS RECEIVED. NO PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62825 CC TIBIAL INSERT SZ 1D, 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. CC TIBIAL INSERT SZ 1D, 15MM UNK 10885862054517

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention