BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 2 11MM

    MDR report key: 19132059 · Received April 18, 2024

    Report

    Report Number
    1038671-2024-00904
    Event Type
    Injury
    Date Received
    April 18, 2024
    Date of Event
    October 27, 2022
    Report Date
    October 17, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001733
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL 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 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.

    Additional Manufacturer Narrative · 0

    D10. H10. PENDING INVESTIGATION. THESE DEVICES ARE USED FOR TREATMENTS, NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE. CONCOMITANTS: 02-010-01-0320 - LOGIC FEMORAL PS CEM RIGHT SZ 2 2150431. 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T 2163153. 200-02-29 - THREE PEG PATELLA 29MM 2533223.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 9 YEARS AND 8 MONTHS AFTER INITIAL IMPLANT. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539592 LOGIC TIBIA PS MOD INSRT SZ 2 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001733

    Patients

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