BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM

    MDR report key: 16461090 · Received March 1, 2023

    Report

    Report Number
    1038671-2023-00299
    Event Type
    Injury
    Date Received
    March 1, 2023
    Date of Event
    December 5, 2022
    Report Date
    April 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862230485
    PMA / PMN Number
    K123342
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PROCODE: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. CONCOMITANT MEDICAL PRODUCTS: 4305374, 02-010-03-0340 - LOGIC CR FEMORAL CEM, RIGHT, SZ 4; 4218280, 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T; 4243095, 200-02-35 - THREE PEG PATELLA 35MM. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    ADDED INFORMATION TO A2, A3, AND UPDATED H6. H6: INVESTIGATION RESULTS - THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: 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 REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL RIGHT TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2016 AND WAS IMPLANTED WITH AN OPTETRAK DEVICE. PLAINTIFF UNDERWENT REVISION SURGERY OF HIS RIGHT KNEE ON (B)(6) 2022, APPROXIMATELY 6 YEARS 7 MONTHS POST INITIAL PROCEDURE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435248 LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM UNK 10885862230485

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention SEE H10