BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 4, 9MM

    MDR report key: 19350695 · Received May 20, 2024

    Report

    Report Number
    1038671-2024-01338
    Event Type
    Injury
    Date Received
    May 20, 2024
    Date of Event
    August 28, 2017
    Report Date
    March 3, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048387
    PMA / PMN Number
    K933610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 1796628 234-03-04 - OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 4, 1803189 200-02-35 - THREE PEG PATELLA 35MM 1847605 200-04-43 - CEMENTED FINNED TIB. TRA SZ 4F/3T THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO PHOTOGRAPHS OR X-RAYS WERE PROVIDED FOR REVIEW; THEREFORE THE REPORTED EVENT CANNOT BE CONFIRMED THROUGH ANALYSIS. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED BASED ON THE INFORMATION MADE AVAILABLE. SHOULD ADDITIONAL, RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR 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. 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. 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 83 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS TIBIAL LOOSENING, TOTAL KNEE ARTHROPLASTY FAILURE DUE TO CYSTIC CHANGE, AND ARTHRITIS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1468790 PS TIBIAL INSERTS SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862048387

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Hospitalization| R SEE H10