BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 38MM

    MDR report key: 22686872 · Received August 1, 2025

    Report

    Report Number
    1038671-2025-02654
    Event Type
    Injury
    Date Received
    August 1, 2025
    Date of Event
    June 26, 2025
    Report Date
    August 19, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039613
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND FRACTURE 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

    THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. D10: 4560935 02-010-03-0350: LOGIC CR FEMORAL CEM, RIGHT, SZ 5. 4490359 02-012-45-5050: LGC TIBIAL FIT TRAY CEM SZ 5F/5T. 2516372 02-012-47-5009: LOGIC CR TIB INSERT STD, SZ 5, 9MM.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 8 YEARS AND 2 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE POLY INSERT AND PATELLA WERE REVISED FOR FAILURE OF THE COMPONENTS AND WEAR. THE INSERT HAD DELAMINATED AND CRACKED. SEVERAL PIECES WERE RECOVERED. THE IMPLANTS WERE REPLACED WITH VIT E IMPLANTS. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2239562 THREE PEG PATELLA 38MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039613

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Hospitalization SEE H11