BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM

    MDR report key: 19297748 · Received May 13, 2024

    Report

    Report Number
    1038671-2024-01201
    Event Type
    Injury
    Date Received
    May 13, 2024
    Date of Event
    April 23, 2024
    Report Date
    March 17, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001771
    PMA / PMN Number
    K093360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D6B, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, G. THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR. THE WEAR MAY HAVE RESULTED FROM HIGH IN VIVO LOADING ON THE POSTERIOR ASPECT OF THE TIBIAL INSERT AND/OR THIRD BODY WEAR, BUT THE POTENTIAL ROOT CAUSES COULD NOT BE CONFIRMED. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND 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.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 132652 620-00-02 - PLATELET RICH PLASMA KIT WITH SPRAY TIPS (B)(6) 02-010-01-0225 - LOGIC FEMORAL PS CEM LEFT SZ 2.5 (B)(6) 02-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T (B)(6) 200-02-32 - THREE PEG PATELLA 32MM.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2015. THE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO A RECALLED POLY. THE POLY WAS SWAPPED OUT FOR A NON-RECALLED ONE. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846225 LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001771

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention