BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS POR RIGHT SZ 2

    MDR report key: 21343517 · Received February 10, 2025

    Report

    Report Number
    1038671-2025-00773
    Event Type
    Injury
    Date Received
    February 10, 2025
    Date of Event
    April 26, 2023
    Report Date
    February 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001399
    PMA / PMN Number
    K123687
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT NUMBER: 1038671-2023-01093. G4: 510K: K123687 AND K140302. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2023-01093. THE REVISION REPORTED WAS LIKELY THE RESULT OF GROSS INSTABILITY, PATIENT-RELATED CONDITIONS, MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND BONE, OR ANY COMBINATION OF THESE POSSIBILITIES, WHICH POLYETHYLENE WEAR OF THE TIBIAL INSERT AND ASEPTIC (NONINFECTED) FEMORAL LOOSENING. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED DUE TO EVOLVING CHRONIC LAXITY, FUNCTIONAL IMPAIRMENT INSTABILITY, FEMORAL METAPHYSEAL PAIN, CHRONIC HYDRARTHROSIS , CYSTS AND WEAR OF PE INSERT WITH FEMORAL GEODE CAVITY FEMORAL LOOSENING. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL INFORMATION PROVIDED. UNABLE TO OBTAIN PHOTOS/X-RAYS. DEVICES HAVE BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960700 LOGIC FEMORAL PS POR RIGHT SZ 2 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001399

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R