BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 4 11MM

    MDR report key: 18716405 · Received February 15, 2024

    Report

    Report Number
    1038671-2024-00233
    Event Type
    Injury
    Date Received
    February 15, 2024
    Date of Event
    May 11, 2011
    Report Date
    October 30, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001894
    PMA / PMN Number
    K033883
    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

    D10. CONCOMITANTS -PRODUCT INFORMATION: 1639271, 02-012-39-4040 - LOGIC TIBIA FIN TRAY CEM SZ 4F/4T; 1813086, 02-010-01-0240 - LOGIC FEMORAL PS CEM LEFT SZ 4; 1841829, 200-02-38 - THREE PEG PATELLA 38MM PENDING INVESTIGATION. THERE IS NO OTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY HAVE BEEN REPORTED AT THIS LATER TIME DUE TO INCLUSION OF ONE OF THE IMPLANTED DEVICES IN THE PACKAGING RECALL. BASED ON LENGTH OF IMPLANTATION, THE REASON FOR REVISION APPEARS UNLIKELY TO BE SECONDARY TO PROSTHESIS WEAR. HOWEVER, THE REPORTED PROSTHESIS WEAR/FAILURE COULD NOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF USER, OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS NO IMAGES OR RADIOGRAPHS WERE PROVIDED, RELEVANT CLINICAL INFORMATION WAS NOT PROVIDED AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2010, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6)2011, APPROXIMATELY 7 MONTHS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223580 LOGIC TIBIA PS MOD INSRT SZ 4 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001894

    Patients

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