BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM

    MDR report key: 17680541 · Received September 4, 2023

    Report

    Report Number
    1038671-2023-02140
    Event Type
    Injury
    Date Received
    September 4, 2023
    Date of Event
    July 27, 2023
    Report Date
    March 13, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174482
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: FEMORAL COMPONENT CR, POROUS SIZE 4, 02-010-04-0340 3756808 CEMENTED FINNED TRAY 4F/4T 200-04-44 2872872 THREE PEG PATELLA, 38MM 200-02-38 3698551 H7: Z-0021-2022.

    Additional Manufacturer Narrative · 0

    H3: THE REASON FOR THE REVISION CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED, BUT MAY BE DUE TO PROSTHESIS WEAR AS REPORTED OR INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THE REPORTED PROSTHESIS WEAR COULD NOT BE CONFIRMED AS NO IMAGES OR RADIOGRAPHS WERE PROVIDED AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION.

    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 OR INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THE REPORTED PROSTHESIS WEAR COULD NOT BE CONFIRMED AS NO IMAGES OR RADIOGRAPHS WERE PROVIDED AND THE DEVICES WERE 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."

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2015. THE PATIENT WAS REVISED ON (B)(6) 2023. EVERYTHING WAS REMOVED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR 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
    1386582 LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 10885862174482

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Hospitalization| R SEE H10