BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR TIBIAL INSERT SZ4, 9MM

    MDR report key: 16633022 · Received March 28, 2023

    Report

    Report Number
    1038671-2023-00529
    Event Type
    Injury
    Date Received
    March 28, 2023
    Date of Event
    February 22, 2021
    Report Date
    February 7, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862040299
    PMA / PMN Number
    K932776
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 2035631 230-03-04 - OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 4, 2070502 204-04-44 - TRAPEZOID TIBIAL TRAY SZ 4F/4T, AND 2332073 200-02-38 - THREE PEG PATELLA 38MM. RECALL #: Z-0019-2022.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3/G4, H6. THE FOLLOWING SECTIONS WERE CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, G. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED BY LEGAL NOTIFICATION, THE MALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2012. THE PATIENT UNDERWENT A REVISION OF THE RIGHT KNEE ON (B)(6) 2017 SECONDARY TO POLYETHYLENE LINER WEAR RESULTING IN EXTENSIVE OSTEOLYSIS, SYNOVITIS, AND ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. THE PATIENT UNDERWENT A SECOND REVISION OF THE RIGHT KNEE ON (B)(6) 2021 SECONDARY TO POLYETHYLENE LINER WEAR WITH RESULTING OSTEOLYSIS AND ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. FIRST REVISION REPORTED UNDER 1038671-2023-00528.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1650149 CR TIBIAL INSERT SZ4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 200-24-09 10885862040299

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention