BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA TC3 FEM RT SZ4

    MDR report key: 8921880 · Received August 22, 2019

    Report

    Report Number
    1818910-2019-101992
    Event Type
    Injury
    Date Received
    August 22, 2019
    Date of Event
    December 14, 2016
    Report Date
    August 1, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295232568
    PMA / PMN Number
    K952830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    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

    SUBJECT ID: (B)(6). DOTS. ON (B)(6) 2016 INDICATE THE PATIENT RECEIVED A REVISION OF TC3 TO HINGED FEMORAL COMPONENT AND TIBIAL INSERT DUE TO PAIN, UNSTABLE AND STIFF RIGHT TOTAL KNEE. IT IS INDICATED WITHIN THE REVISION NOTES THAT THE PATIENT HAS BEEN DIAGNOSED WITH A CEMENT ALLERGY, NO ADDITIONAL INFORMATION IS PROVIDED REGARDING THIS. DOI: (B)(6) 2015. DOR: (B)(6) 2016. (RIGHT KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715736 PFC*SIGMA TC3 FEM RT SZ4 SIGMA REVISION IMPLANT : KNEE FEMORAL JWH DEPUY ORTHOPAEDICS INC US 636327 10603295232568

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention