BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3 13MM

    MDR report key: 19125693 · Received April 17, 2024

    Report

    Report Number
    1038671-2024-00893
    Event Type
    Injury
    Date Received
    April 17, 2024
    Date of Event
    April 15, 2024
    Report Date
    December 4, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001825
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H7 - RECALL NUMBER Z-0021-2022 H3 - PENDING INVESTIGATION D10 CONCOMITANTS: 02-010-01-0330 - LOGIC FEMORAL PS CEM RIGHT SZ 3, SERIAL NUMBER (B)(6), 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T, SERIAL NUMBER (B)(6), 200-02-38 - THREE PEG PATELLA 38MM, 2923903

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D6B, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS) THE FOLLOWING SECTIONS WERE CORRECTED: H6 (HEALTH EFFECT - CLINICAL CODE). 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. 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. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A PATIENT HAS A PLANNED KNEE ARTHROPLASTY REVISION SCHEDULED FOR (B)(6) 2024 BY (B)(6). RECORDS SEARCH LOCATED AN INITIAL SURGERY FOR (B)(6) BY(B)(6) ON (B)(6) 2014. COMPONENTS IMPLANTED ARE LISTED BELOW AND ATTACHED. AT THE TIME OF LEGAL NOTIFICATION: THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE, THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME, THERE IS NO DEVICE RETURNED, THERE ARE NO PHOTOS, RADIOGRAPHS OR OTHER IMAGES OF THE DEVICE PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1914741 LOGIC TIBIA PS MOD INSRT SZ 3 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001825

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown Required Intervention SEE H10.