BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM

    MDR report key: 18826933 · Received March 4, 2024

    Report

    Report Number
    1038671-2024-00382
    Event Type
    Injury
    Date Received
    March 4, 2024
    Date of Event
    April 27, 2023
    Report Date
    November 14, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001771
    PMA / PMN Number
    K093360
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: (B)(6), 02-010-01-0325 - LOGIC FEMORAL PS CEM RIGHT SZ 2.5. (B)(6), 02-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T. (B)(6), 2-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T. (B)(6), 00-02-32 - THREE PEG PATELLA 32MM. (B)(6), 00-02-32 - THREE PEG PATELLA 32MM. PENDING INVESTIGATION. THESE DEVICES ARE USED FOR TREATMENT, NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND INSTABILITY 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 RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 7 YEARS AND 8 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO DEVICE INFORMATION PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710574 LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001771

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention