BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC

    MDR report key: 16448797 · Received February 27, 2023

    Report

    Report Number
    1038671-2023-00255
    Event Type
    Injury
    Date Received
    February 27, 2023
    Date of Event
    February 2, 2023
    Report Date
    March 6, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174130
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE REASON FOR THE REVISION IN (B)(4) CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED, BUT MAY BE DUE TO PROSTHESIS WEAR AS REPORTED, PATIENT CONDITIONS, OR INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED, BUT MAY BE DUE TO PROSTHESIS WEAR AS REPORTED, PATIENT CONDITIONS, OR INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. 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

    PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER,METAL,POLYMER. CONCOMITANT MEDICAL PRODUCTS:¿ (B)(4) 02-010-03-0310 - LOGIC CR FEMORAL CEM, RIGHT, SZ 1, (B)(4) 02-012-45-1010 - LGC TIBIAL FIT TRAY CEM SZ 1F / 1T, (B)(4) 200-02-32 - THREE PEG PATELLA 32MM. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2015, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 7 YEARS 3 MONTHS POST THE INITIAL PROCEDURE DUE TO PAIN. THE BONE SCAN AND MRI DID NOT SHOW MUCH PER THE SURGEON¿S PA. POLY EXCHANGED. SOME WEAR AND POSSIBLE OXIDATION WERE NOTED ON THE MEDIAL SIDE OF THE INSERT. A MORE CONSTRAINED 9 CRC WAS IMPLANTED. THERE WERE NO COMPLICATIONS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. EXPLANTS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384946 LOGIC SEE H10 JWH EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 1, 9MM UNK 10885862174130

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10.