BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC

    MDR report key: 15709443 · Received November 1, 2022

    Report

    Report Number
    1038671-2022-01384
    Event Type
    Injury
    Date Received
    November 1, 2022
    Date of Event
    October 3, 2022
    Report Date
    March 19, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001764
    PMA / PMN Number
    K093360
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: 02-010-01-0225 - LOGIC FEMORAL PS CEM LEFT SZ 2.5, 4731451; 02-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T, 4873692; 200-02-35 - THREE PEG PATELLA 35MM, 4485884. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR WHICH MAY HAVE BEEN DUE TO A COMBINATION OF AXIAL ROTATION MISMATCH BETWEEN THE TIBIAL AND FEMORAL COMPONENTS, PATIENT-RELATED CONDITIONS, AND/OR OXIDATIVE DEGRADATION OF THE POLYETHYLENE DUE TO BEING PACKAGED IN A NON-CONFORMING BAG FOR FIVE YEARS. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. 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

    AFTER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS, HAVE BEEN UPDATED ACCORDINGLY: H6: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR WHICH MAY HAVE BEEN DUE TO A COMBINATION OF AXIAL ROTATION MISMATCH BETWEEN THE TIBIAL AND FEMORAL COMPONENTS, PATIENT-RELATED CONDITIONS, AND/OR OXIDATIVE DEGRADATION OF THE POLYETHYLENE DUE TO BEING PACKAGED IN A NON-CONFORMING BAG FOR FIVE YEARS. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO HAD AN INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE DUE TO PAIN AND STIFFNESS, ON (B)(6) 2022, APPROXIMATELY 5 YEARS POST THE INITIAL PROCEDURE. THE SURGEON NOTED SIGNIFICANT SYNOVITIS, SEVERAL OSTEOPHYTES, AND SIGNIFICANT POLY WEAR. AFTER PERFORMING RELEASES, A NEW PS 9MM INSERT WAS IMPLANTED. PATIENT LEFT IN STABLE CONDITION. EXPLANTS NOT AVAILABLE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227566 LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 2.5 9MM UNK 10885862001764

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention