BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 5 11MM

    MDR report key: 19085898 · Received April 11, 2024

    Report

    Report Number
    1038671-2024-00796
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    May 26, 2020
    Report Date
    October 11, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001931
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10. D10. CONCOMITANT PRODUCTS: (B)(6) - 02-010-01-0250 - LOGIC FEMORAL PS CEM LEFT SZ 5 (B)(6) - 02-012-42-5008 - LOGIC PTS, SIZE 5, 8MM (B)(6) - 02-012-45-5040 - LGC TIBIAL FIT TRAY CEM SZ 5F / 4T (B)(6) - 1510-S - CEMEX SYSTEM FAST 70 GM (B)(6) - 200-02-38 - THREE PEG PATELLA 38MM (B)(6) - 201-78-88 - 4" DRILL BIT, MOD. HEX 2-PK (B)(6) - 201-78-88 - 4" DRILL BIT, MOD. HEX 2-PK (B)(6) - ASA0030 - STERILE DISPOSABLE CONTAINERS. THESE DEVICES ARE USED FOR TREATMENTS, NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. THE REASON THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY HAVE BEEN REPORTED AT THIS LATER TIME DUE TO INCLUSION OF ONE OF THE IMPLANTED DEVICES IN THE PACKAGING RECALL. HOWEVER, THE REPORTED PROSTHESIS WEAR COULD NOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2020 APPROXIMATELY 4 YEARS AND 9 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691142 LOGIC TIBIA PS MOD INSRT SZ 5 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001931

    Patients

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