BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3 11MM

    MDR report key: 19417426 · Received May 29, 2024

    Report

    Report Number
    1038671-2024-01550
    Event Type
    Injury
    Date Received
    May 29, 2024
    Date of Event
    November 2, 2022
    Report Date
    November 11, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CORRECTED HEALTH EFFECT - CLINICAL CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS." THE REASON FOR THE REVISION REPORTED IN 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. ADDITIONALLY, THESE DEVICES APPEAR TO HAVE BEEN IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED EVENT. 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

    H10. D10. CONCOMITANTS - PRODUCT INFORMATION: 1766485 - 201-46-10 - HOLDING PIN HEADLESS 3" (4 PK); 1926798 - 204-34-04 - FLUTED STEM EXTENSION 40L X 14 MM; 8931093 - 208-01-02 - CC FEMORAL SZ 2; 1884976 - 208-09-05 - CC STEM EXT ADAPTOR 5 DEGREE PENDING INVESTIGATION. THERE IS NO OTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT KNEE ARTHROPLASTY ON (B)(6) 2010, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2022, APPROXIMATELY 11 YEARS, 11 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
    586725 LOGIC TIBIA PS MOD INSRT SZ 3 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention