BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC KNEE COMPONENTS

    MDR report key: 23934518 · Received December 31, 2025

    Report

    Report Number
    1038671-2025-03656
    Event Type
    Injury
    Date Received
    December 31, 2025
    Date of Event
    November 18, 2025
    Report Date
    March 6, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H3, H6, H11. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. INFORMATION REGARDING THE REASON FOR THE REVISION WAS NOT PROVIDED. DUE TO THE LIMITED INFORMATION, THIS COMPLAINT EVENT CANNOT BE FURTHER INVESTIGATED OR CONFIRMED, AND A DEFINITIVE CAUSE, IN ADDITION TO ANY POTENTIAL PRODUCT, PATIENT, AND/OR USER-RELATED CONTRIBUTING FACTORS CANNOT BE DEFINITIVELY DETERMINED. THERE IS NO INDICATION WITHIN THE AVAILABLE INFORMATION THAT A NEW OR UNEXPECTED FAILURE MODE OR HARM/ADVERSE EVENT TYPE HAS OCCURRED OR THAT THE BENEFIT-RISK ANALYSIS FOR THESE PRODUCTS HAS BEEN ALTERED; THEREFORE, NO FURTHER RISK ANALYSIS WILL BE PERFORMED. HOWEVER, THIS EVENT WILL BE INCLUDED IN COMPLAINT TRENDING. COMPLAINT TRENDING AND ACTIONS WILL BE TAKEN AS REQUIRED UPON DETECTION OF ANY TREND SIGNALS. NO FURTHER ACTION OR ESCALATION WILL BE TAKEN AT THIS TIME CONCERNING THIS REPORTED EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED CONCERNING THIS EVENT, THE COMPLAINT INVESTIGATION WILL BE RE-OPENED AND ACTIONS WILL BE TAKEN AS APPROPRIATE AND A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    D10: 02-010-04-0240 - LOGIC CR FEMORAL POR, LEFT, SZ 4, 3818569. 02-012-45-4030 - LGC TIBIAL FIT TRAY CEM SZ 4F / 3T, 4135346. 02-012-49-4009 - LOGIC CR TIB INSERT SLOPE++, SZ 4, 9MM, 2767755. 200-02-35 - THREE PEG PATELLA 35MM, 3983141. A10012 - GPS IMPLANT KIT V2, 9032015024. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALE PATIENT, WHO HAD LEFT TKA, UNDERWENT A REVISION PROCEDURE, APPROXIMATELY 9 YEARS 7 MONTHS POST THE INITIAL PROCEDURE. REASON FOR THE REVISION IS UNKNOWN. THE PATIENT WAS NOT REVISED TO SAME COMPANY DEVICES. ALL DEVICES WERE REMOVED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THEY WERE DISPOSED OF BY THE HOSPITAL. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2793184 LOGIC KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H11.