BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM

    MDR report key: 15395269 · Received September 9, 2022

    Report

    Report Number
    1038671-2022-01086
    Event Type
    Injury
    Date Received
    September 9, 2022
    Date of Event
    March 31, 2022
    Report Date
    November 15, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001849
    PMA / PMN Number
    K093360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. CONCOMITANTS: 02-010-01-0335 - LOGIC FEMORAL PS CEM RIGHT SZ 3.5 SN: (B)(4), 02-012-41-3535 - LOGIC TIBIA TRAPTRAY CEM SZ 3.5F/3.5T SN: (B)(4), 200-02-35 - THREE PEG PATELLA 35MM SN: (B)(4), 201-46-10 - HOLDING PIN HEADLESS 3" (4 PK) SN: (B)(4).

    Additional Manufacturer Narrative · 0

    H7: Z-0021-2022.

    Additional Manufacturer Narrative · 0

    DUPLICATE CASE. SEE 1038671-2022-00438.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL, THAT A FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2012, WAS REVISED ON (B)(6) 2022 APPROXIMATELY 9 YEARS 11 MONTHS POST THE INITIAL IMPLANT PROCEDURE FOR UNKNOWN REASONS. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION.

    Description of Event or Problem · 0

    THIS IS A DUPLICATE. THIS EVENT HAS ALREADY BEEN REPORTED UNDER 1038671-2022-00438.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360150 LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM UNK 10885862001849

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention SEE H10