BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLEX

    MDR report key: 20449176 · Received October 15, 2024

    Report

    Report Number
    9615014-2024-00012
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    September 20, 2024
    Report Date
    October 15, 2024
    Manufacturer
    OSARTIS GMBH
    Product Code
    LOD
    UDI-DI
    04260056885747
    PMA / PMN Number
    K123225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(6) 2015: RIGHT MEDIAL MCK UNI KNEE EXCHANGE (B)(6) 2024: I&D ON A RIGHT KNEE THAT HAD AN MCK UNI ON BOTH THE MEDIAL AND LATERAL SIDES. (B)(6) 2024: REVISION OF TIBIAL INSERT, DUE TO SUSPECTED INFECTION. THIS REPORT IS DUE TO THE INFECTION REVISED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35881 SIMPLEX SIMPLEX HV LOD OSARTIS GMBH 6194-1-001 333AB922IE 04260056885747

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other MCK FEMORAL-LM-RL-SZ 3REF 180503LOT CPB4-1| MCK FEMORAL-RM-LL-SZ 3REF 180513LOT 26240615-01| MCK PATELLOFEMORAL-R-SZ 3REF 180413LOT A6LM-1| MCK TIB BASEPLATE-LM/RLREF 180603LOT 26031023-01| MCK TIB BASEPLATE-RM/LLREF 180614LOT 26480815-01| MCK TIB ONLAY INSERTREF 180704-1LOT 12120515-2| PALACOS R +GREF 00-1113-140-01LOT 82054447| TRITANIUM PATELLA-ASYMREF 5552-L-299LOT WJX31| X3 UNI ONLAY TIB INSERTREF 180733-1-ELOT 9R4KK0