BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LPS UNIV TIB HIN INS XXSM 18MM

    MDR report key: 3020514 · Received March 26, 2013

    Report

    Report Number
    1818910-2013-14421
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    KRO
    PMA / PMN Number
    PK091453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS DISENGAGEMENT OF THE TIBIAL INSERT'S POST FROM THE BASEPLATE WHICH OCCURRED WHEN PATIENT HYPERFLEXED HER KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124091 LPS UNIV TIB HIN INS XXSM 18MM TIBIAL KNEE INSERT KRO 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention