BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE ++, SZ 1.5, 13 MM

    MDR report key: 19122193 · Received April 16, 2024

    Report

    Report Number
    1038671-2024-00873
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    March 25, 2024
    Report Date
    June 9, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862144423
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): (B)(6); 02-010-03-0315 - LOGIC CR FEMORAL CEM, RIGHT, SZ 1.5. (B)(6); 02-012-45-1515 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T. (B)(6); 200-02-26 - THREE PEG PATELLA 26MM.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED WAS LIKELY THE RESULT OF THE REPORTED PAIN, WHICH WAS CAUSED BY PROSTHESIS WEAR AND INSTABILITY, OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL, OR ANY COMBINATION OF THESE POSSIBILITIES. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 70 YO FEMALE PATIENT, INITIAL (B)(6) 2016, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 7 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT RETURNED TO THE SURGEON¿S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED POLY IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS FULL REVISION. THE PATIENT UNDERWENT POLY TIBIAL INSERT SWAP AND PATELLA SWAP AND WAS REVISED TO A TRULIANT CRC TIBIAL INSERT SZ 1.5 , 15MM SN: (B)(6) AND AN OPTETRAK 3 PEG PATELLA 29MM SN: (B)(6). THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. NO X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THEY WERE SENT TO LAB AND LEGAL AT THE HOSPITAL. A DEVICE IMAGE WAS PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1856222 LOGIC CR TIB INSERT SLOPE ++, SZ 1.5, 13 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862144423

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female SEE H10.