BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR TIBIAL INSERT SZ4, 9MM

    MDR report key: 16632994 · Received March 28, 2023

    Report

    Report Number
    1038671-2023-00528
    Event Type
    Injury
    Date Received
    March 28, 2023
    Date of Event
    September 12, 2017
    Report Date
    January 29, 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

    H3: THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF POLYETHYLENE LINER WEAR, OSTEOLYSIS, AND ASEPTIC TIBIAL LOOSENING AS STATED IN THE LEGAL DOCUMENTATION. THE ASEPTIC (NON-INFECTED) TIBIAL LOOSENING MAY HAVE BEEN THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE TIBIAL TRAY AND THE BONE. THE EXTENT AND ROOT CAUSE OF THE REPORTED POLYETHYLENE WEAR AND OSTEOLYSIS CANNOT BE DETERMINED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RADIOGRAPHS, PHOTOGRAPHS, AND OPERATIVE NOTES WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL DEVICES: EXACTECH TIBIAL TRAY, CATALOG NO. 204-04-44, LOT NO. 2070502; AND EXACTECH FEMORAL COMPONENT, CATALOG NO. 30-03-04, LOT NO. 2035631. CORRECTION/REMOVAL NUMBER: Z-0019-2022.

    Additional Manufacturer Narrative · 0

    1038671-2025-00537 MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 1038671-2025-00537. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS). THE FOLLOWING SECTIONS WERE CORRECTED: H6 (HEALTH EFFECT - CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE). THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY, AND TIBIAL LOOSENING. 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 REVISION SURGERY ON (B)(6) 2017 SECONDARY TO POLYETHYLENE LINER WEAR RESULTING IN EXTENSIVE OSTEOLYSIS, SYNOVITIS, AND ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2008011 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 SEE H10