BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 6, 9MM

    MDR report key: 18344865 · Received December 18, 2023

    Report

    Report Number
    1038671-2023-03003
    Event Type
    Injury
    Date Received
    December 18, 2023
    Date of Event
    December 10, 2023
    Report Date
    November 6, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K121307
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: 6071361 02-010-04-0360 - LOGIC CR FEMORAL POR, RIGHT, SZ 6 3817740 02-012-45-6050 - LGC TIBIAL FIT TRAY CEM SZ 6F / 5T. 6499722 200-02-38 - THREE PEG PATELLA 38MM. 6193949 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. 4090786 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. S032531 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. S042629 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. H7: Z-0021-2022.

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR. A CONTRIBUTING FACTOR TO THE EXTENT OF WEAR ON THE TIBIAL INSERT MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING BAG FOR MORE THAN 5 YEARS. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION AND ADDITIONAL INFORMATION REGARDING PATIENT-RELATED CONDITIONS OR OTHER CONTRIBUTING FACTORS WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) INVESTIGATION CONCLUSION.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2020. THE PATIENT WAS REVISED ON (B)(6) 2023. THE X-RAY SHOWED EXCESSIVE POLY WEAR. THIS PATIENT WAS PART OF THE KNEE RECALL. 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
    79690 LOGIC CR TIB INSERT STD, SZ 6, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention SEE H10