BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CC TIBIAL INSERT SZ 3, 18MM

    MDR report key: 19574001 · Received June 20, 2024

    Report

    Report Number
    1038671-2024-02032
    Event Type
    Injury
    Date Received
    June 20, 2024
    Date of Event
    December 19, 2023
    Report Date
    February 11, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862054289
    PMA / PMN Number
    K954208
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0019-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 208-23-18 - 1163109 -CC TIBIAL INSERT SZ 3, 18MM. 200-02-32 - THREE PEG PATELLA 32MM. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE ADDED/CORRECTED: D10, H6: CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION. THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR OF THE INSERT AND PATELLA, FRACTURE OF THE SPINE STIFFENING SCREW, AND LOOSENING OF THE TIBIAL TRAY AND FEMORAL COMPONENT OVER THE 14.5 YEARS OF IMPLANTATION. THE UNDERLYING CAUSE AND SEQUENCE OF EVENTS CANNOT BE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED, AND NO IMAGES OR RADIOGRAPHS WERE 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

    IT WAS REPORTED THAT APPROXIMATELY 175 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, GROSSLY LOOSE FEMUR, TIBIAL INSERT, TIBIA, PATELLA, BROKEN POLY LOCKING SCREW, MASSIVE BONE LOSS IN THE FEMUR AND TIBIA, MARKED BONE LOSS IN THE PATELLA, ADVANCED WEAR AND OXIDATION ON TIBIAL INSERT AND PATELLA. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455210 CC TIBIAL INSERT SZ 3, 18MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862054289

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R