BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMARP STB TB IN 5 17.5

    MDR report key: 10862680 · Received November 18, 2020

    Report

    Report Number
    1818910-2020-24939
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    January 23, 2009
    Report Date
    November 4, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    UDI-DI
    10603295241430
    PMA / PMN Number
    -
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: PRODUCT CODE 962154, WORK ORDER (B)(4), WAS MANUFACTURED ON 23 MAY 2007. (B)(4) PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. NO NON-CONFORMANCES OR DEVIATIONS WERE IDENTIFIED AGAINST THIS LOT.

    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.

    Description of Event or Problem · 1

    CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS INSTABILITY. DATE OF IMPLANTATION: (B)(6) 2007, DATE OF REVISION: (B)(6) 2009, (LEFT KNEE). TREATMENT: REVISION OF TIBIAL INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1324557 PFC SIGMARP STB TB IN 5 17.5 SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT NJL DEPUY ORTHOPAEDICS INC US 96-2154 2388840 10603295241430

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention MBT CEM KEEL TIB TRAY SZ4.| PFC*SIGMA C/S NPOR FEM LT SZ 5.| PFC*SIGMA/OV/DOME PAT 3PEG,41.| SMARTSET HV BONE CEMENT 40G.| SMARTSET HV BONE CEMENT 40G.| SMARTSET HV BONE CEMENT 40G.| MBT CEM KEEL TIB TRAY SZ4| PFC*SIGMA C/S NPOR FEM LT SZ 5| PFC*SIGMA/OV/DOME PAT 3PEG,41| SMARTSET HV BONE CEMENT 40G| SMARTSET HV BONE CEMENT 40G| SMARTSET HV BONE CEMENT 40G