BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR FEMORAL POR, RIGHT, SZ 6

    MDR report key: 21106666 · Received January 8, 2025

    Report

    Report Number
    1038671-2025-00160
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    June 14, 2017
    Report Date
    March 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862158413
    PMA / PMN Number
    K123687
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND FEMORAL 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. 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: 4795962 02-012-45-6060 - LGC TIBIAL FIT TRAY CEM SZ 6F / 6T, 3980638 200-02-41 - THREE PEG PATELLA 41MM. 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. 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

    APPROXIMATELY 5 YEARS AND 8 MONTHS AFTER INITIAL IMPLANTATION OF LEFT TOTAL KNEE ARTHROPLASTY IN (B)(6) 2016, IT WAS REPORTED VIA LEGAL NOTIFICATION THAT A PATIENT EXPERIENCED PROGRESSIVE/INCREASED PAIN AND SWELLING ASSOCIATED WITH ASEPTIC LOOSENING. THE PATIENT WAS SURGICALLY REVISED IN (B)(6) 2022, ADDITIONALLY NOTING RADIOGRAPHS SHOWED LOOSENING ABOUT THE FEMORAL COMPONENT. THERE WAS AN ABUNDANT SYNOVIAL INFLAMMATION PRESENT. INSPECTION OF THE COMPONENTS SHOWED THAT THERE WAS EVIDENCE OF WEAR DEBRIS ON THE MEDIAL FEMUR POLYETHYLENE POSTERO-MEDIALLY. THERE WAS OBVIOUS LOOSING OF THE FEMORAL COMPONENT. THE TIBIAL COMPONENT WAS SECURELY FIXED. THE PATELLA WAS IN APPROPRIATE POSITION. THE KNEE WAS STABLE AFTER REVISION. NO COMPLICATIONS DURING THE SURGICAL PROCEDURE. THERE ARE NO RADIOGRAPHIC IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1537126 LOGIC CR FEMORAL POR, RIGHT, SZ 6 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862158413

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Hospitalization SEE H11.