BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR TIBIAL INSERT SZ 2, 11MM, SLOPE ++

    MDR report key: 17875425 · Received October 5, 2023

    Report

    Report Number
    1038671-2023-02456
    Event Type
    Injury
    Date Received
    October 5, 2023
    Date of Event
    September 17, 2021
    Report Date
    January 31, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862041227
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: ASYMMETRIC CR FEMORAL COMPONENT (230-03-02, 2113689); TRAPEZOIDAL TIBIAL TRAY (204-04-22, 2068372); PATELLA (200-02-35, 2123341); EXACTECH CEMEX BONE FAST TRACK (1510/S, AA4681). PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    H3: INVESTIGATION RESULTS - THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR OF THE POSTERIOR MEDIAL ASPECT OF THE TIBIAL INSERT. THIS MAY BE RELATED TO EXCESSIVE OVERALL POSTERIOR TIBIAL SLOPE OF THE TIBIAL INSERT. THE EXTENT AND ROOT CAUSE OF THIS PROSTHESIS WEAR COULD NOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2011. APPROXIMATELY 5 YEARS AND 10 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2017 WITH COMPETITORS PRODUCTS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON (B)(6) 2017 DIAGNOSIS: COMPLETE POLYETHYLENE FAILURE WITH METAL ON METAL ARTICULATION METALLOSIS STAINING OF THE SYNOVIUM. THEY THEN DID A SUBTOTAL SYNOVECTOMY TAKING OUT ALL TISSUE AROUND THE SYNOVIUM THAT WAS DARK AND BLACKENED AS MUCH AS WAS REASONABLE DUE TO BEING AROUND EITHER LIGAMENTOUS STRUCTURES OR NEUROVASCULAR STRUCTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342808 CR TIBIAL INSERT SZ 2, 11MM, SLOPE ++ PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. UNK 10885862041227

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention