BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CC TIBIAL INSERT SZ 2, 26MM

    MDR report key: 20344963 · Received October 1, 2024

    Report

    Report Number
    1038671-2024-03769
    Event Type
    Injury
    Date Received
    October 1, 2024
    Date of Event
    November 14, 2023
    Report Date
    May 15, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862054227
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6 (TYPE OF INVESTIGATION). THE FOLLOWING SECTIONS WERE CORRECTED: H6 (HEALTH EFFECT - CLINICAL CODE). 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, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: (2200194), 204-32-12 - STEM EXTENSION 120L X12 MM; (3614677), 204-34-12 - FLUTED STEM EXTENSION 120L X 14 MM; (3710951), 204-04-22 - TRAPEZOID TIBIAL TRAY SZ 1F/2T, 2F/2T; (3780992), 204-70-00 - TIBIAL STEM EXT. SCREW; (3902927), 208-09-05 - CC STEM EXT ADAPTOR 5 DEGREE; (3912531), 208-01-02 - CC FEMORAL SZ 2; (4009932), 208-06-02 - CC DISTAL FEM AUGMENT SZ 2, 10MM; (4009938), 208-06-02 - CC DISTAL FEM AUGMENT SZ 2, 10MM; (4053463), 201-78-78 - 4"" DRILL BIT, HEX, 2 PK. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 97 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45972 CC TIBIAL INSERT SZ 2, 26MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862054227

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11.