BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC KNEE COMPONENTS

    MDR report key: 12388991 · Received August 30, 2021

    Report

    Report Number
    1038671-2021-00452
    Event Type
    Injury
    Date Received
    August 30, 2021
    Date of Event
    August 9, 2021
    Report Date
    March 25, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS G3, G6, H2, H3 AND H6 HAVE BEEN UPDATED ACCORDINGLY. (H3) AS REPORTED, A 67 Y/O MALE WAS SEEN BY HIS SURGEON REGARDING HIS LKA. REASON NOT REPORTED. UPON REVIEW, THERE IS NO ALLEGATION AGAINST THE DEVICE AS THE REASON FOR REVISION WAS NOT REPORTED. THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS PATIENT CONDITIONS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY SEVEN YEARS POST LTKA, (B)(6) MALE PATIENT WAS SEEN BY HIS SURGEON FOR A REASON NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1284462 LOGIC KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC KNEE COMPONENTS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention