BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM

    MDR report key: 15574387 · Received October 11, 2022

    Report

    Report Number
    1038671-2022-01276
    Event Type
    Injury
    Date Received
    October 11, 2022
    Date of Event
    March 10, 2022
    Report Date
    October 13, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862159144
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE RETURN ANTICIPATED AS THE HOSPITAL IS REFUSING TO RETURN. CONCOMITANTS: 02-010-03-0225 - LOGIC CR FEMORAL CEM, LEFT SZ 2.5, 4726433; 02-012-45-2515 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 1.5T, 4463789; 02-012-47-2509 - LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM, 2121452; 200-02-29 - THREE PEG PATELLA 29MM, 4668232. RECALL: Z-0021-2022. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H6: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT POLY SWAP/REVISION HAS BEEN REPORTED TO BE DUE TO THE DEVICE RECALL; NO OTHER REASON REPORTED. B5: INITIAL HIP IMPLANTED WAS THE LEFT HIP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 66 YO FEMALE PATIENT, INITIAL RIGHT HIP IMPLANTED ON (B)(6) 2017, WAS REVISED ON OR ABOUT (B)(6) 2022, APPROXIMATELY 4 YEARS 9 MONTHS POST THE INITIAL PROCEDURE. THE MD REQUESTED POLY SWAP DUE TO RECALL. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT RETURNING AS THE HOSPITAL REFUSED TO RETURN.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2898700 LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM UNK 10885862159144

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention| H SEE H10.