BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMARP CV TB/IN S4 15.0

    MDR report key: 6830980 · Received August 30, 2017

    Report

    Report Number
    1818910-2017-23732
    Event Type
    Injury
    Date Received
    August 30, 2017
    Date of Event
    August 1, 2017
    Report Date
    August 1, 2017
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    NJL
    UDI-DI
    10603295240839
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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

    IT WAS INDICATED THAT POLYETHYLENE FRACTURE OF 962043, 4X15 RP CR INSERT SECONDARY TO INSTABILITY REPLACED WITH A 4X17.5 RP CR TIBIAL INSERT. UPDATE 8-1-2017: MEDICAL RECORDS HAVE BEEN REVIEWED. OPERATIVE NOTE (B)(6) 2009 INDICATES THE PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT DUE TO DEGENERATIVE JOINT DISEASE OF THE RIGHT KNEE. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATION NOTED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610763 PFC SIGMARP CV TB/IN S4 15.0 KNEE TIBIAL BEARING/INSERT NJL DEPUY IRELAND 9616671 2856609 10603295240839

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention