BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMARP STB TB IN 2.5 10.0

    MDR report key: 9412065 · Received December 4, 2019

    Report

    Report Number
    1818910-2019-120266
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    November 11, 2019
    Report Date
    November 11, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    UDI-DI
    10603295241171
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS IS A DUPLICATE REPORT OF (MFR NO.) 1818910-2019-120377. 1818910-2019-120266 IS BEING RETRACTED AS IT IS A REPORT DUPLICATION. 1818910-2019-120377 WILL BE KEPT FOR INVESTIGATIONAL PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO PAINFUL KNEE. PREVIOUS SURGERY DATE UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204880 PFC SIGMARP STB TB IN 2.5 10.0 SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT NJL DEPUY ORTHOPAEDICS INC US NI 10603295241171

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention