BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 11MM

    MDR report key: 19132865 · Received April 18, 2024

    Report

    Report Number
    1038671-2024-00910
    Event Type
    Injury
    Date Received
    April 18, 2024
    Date of Event
    November 1, 2023
    Report Date
    November 1, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173485
    PMA / PMN Number
    K110547
    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. CONCOMITANTS: (B)(6) 02-012-42-2008 - LOGIC PTS, SIZE 2, 8MM (B)(6) 208-05-02 - CC DISTAL FEM AUGMENT SZ 2, 5MM (B)(6) 02-010-06-0522 - TRU POST. AUG. SIZE 2, 10MM (B)(6) 02-012-60-1416 - TRU STEM EXT 14MM X 160MM (B)(6) 02-010-06-0220 - TRU CC FEMORAL SIZE 2 LEFT (B)(6) 208-06-02 - CC DISTAL FEM AUGMENT SZ 2, 10MM (B)(6) 02-012-61-6000 - TRU OFFSET STEM EXT COUPLER, 6MM 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 MANUFACTURER NARRATIVE UPDATED: 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, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT 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) 2017, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 6 YEARS AND 10 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
    499195 LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862173485

    Patients

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