BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3 9MM

    MDR report key: 18855622 · Received March 7, 2024

    Report

    Report Number
    1038671-2024-00426
    Event Type
    Injury
    Date Received
    March 7, 2024
    Date of Event
    July 26, 2018
    Report Date
    October 31, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001801
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: THE REASON FOR THE REPORTED EVENT IN (B)(4) CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED, BUT MAY HAVE BEEN DUE TO PROSTHESIS WEAR. 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. ADDITIONALLY, THIS DEVICE WAS NOT PACKAGED IN A NON-CONFORMING VACUUM BAG.

    Additional Manufacturer Narrative · 0

    H10. D10. CONCOMITANTS: 02-012-45-3020 - LGC TIBIAL FIT TRAY CEM SZ 3F / 2T 5241695 02-020-11-0230 - TRULIANT PS CEM FEM PS CEM LEFT SZ 3 5469775 201-00-02 - GPS DAILY RENTAL FEE UNASSIGNED THESE DEVICES ARE USED FOR TREATMENT AND DIAGNOSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. PENDING INVESTIGATION.

    Description of Event or Problem · 0

    IT IS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018, WITH NO REVISION SURGERY REPORTED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2341260 LOGIC TIBIA PS MOD INSRT SZ 3 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001801

    Patients

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