BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIB INSERT IMPL CRC, SZ 4, 11MM

    MDR report key: 15537129 · Received October 4, 2022

    Report

    Report Number
    1038671-2022-01234
    Event Type
    Injury
    Date Received
    October 4, 2022
    Date of Event
    September 12, 2022
    Report Date
    December 31, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862230492
    PMA / PMN Number
    K123342
    Removal / Correction Number
    Z-0021-2022
    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 EVALUATION. CONCOMITANT DEVICE(S): 02-010-04-0340 - LOGIC CR FEMORAL POR, RIGHT, SZ 4 4719880, 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T 6029557, 200-02-41 - THREE PEG PATELLA 41MM 4481559,

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS MOST LIKELY THE RESULT OF PROSTHESIS WEAR INITIATED BY UNINTENDED CONTACT BETWEEN INCONGRUENT SURFACES OF THE TIBIAL INSERT AND FEMORAL COMPONENT. HOWEVER, CONTRIBUTIONS FROM INSTABILITY OF THE KNEE JOINT, COMPONENT ALIGNMENT, AND/OR PATIENT-CONDITIONS TO THE SEQUENCE OF EVENTS CANNOT BE DETERMINED FROM THE REPORTED CLINICAL INFORMATION. HAVING BEEN PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS MAY ALSO HAVE BEEN CONTRIBUTING FACTOR TO THE EXTENT OF WEAR NOTED ON THE TIBIAL INSERT. THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) COMPONENT CODE: 734, BEARINGS.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 1.5 YEARS POST OP THE INITIAL RIGHT TKA, THIS FEMALE PATIENT WAS REVISED DUE TO A SWOLLEN KNEE AND PAIN CAUSED DUE TO POLY WEAR FROM THE BAD BATCH OF POLY. INSERT AND PATELLA CHANGED. PATIENT REVISED TO EXACTECH DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2506688 LOGIC TIB INSERT IMPL CRC, SZ 4, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-012-51-4011 UNK 10885862230492

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H10.