BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC

    MDR report key: 21300701 · Received February 3, 2025

    Report

    Report Number
    1038671-2025-00629
    Event Type
    Injury
    Date Received
    February 3, 2025
    Report Date
    February 3, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 200-00-00 - KNEE ITEM-MISC, (B)(6), 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, (B)(6), 02-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T, (B)(6), 02-010-03-0325 - LOGIC CR FEMORAL CEM, RIGHT, SZ 2.5, (B)(6), 201-78-14 - HOLDING PIN HEADLESS SHARP POINT LONG 4PK, (B)(6), 200-02-35 - THREE PEG PATELLA 35MM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED IN (B)(6) 2012, UNDERWENT A REVISION PROCEDURE IN 2013. PARTY STATED SHE RECEIVED A DEFECTIVE KNEE REPLACEMENT. PARTY STATED THAT HER IMPLANT SLIPPED OUT OF PLACE AND NEEDS TO HAVE A SECOND SURGERY, BECAUSE IT HAS BEEN CAUSING HER PAIN AND DIFFICULTY WALKING. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245687 OPTETRAK LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SEE H11