BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC*SIGMA/OV/DOME PAT 3PEG,35

    MDR report key: 10222623 · Received July 2, 2020

    Report

    Report Number
    1818910-2020-14902
    Event Type
    Malfunction
    Date Received
    July 2, 2020
    Date of Event
    June 17, 2020
    Report Date
    June 17, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295232612
    PMA / PMN Number
    K961685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4) THIS PRODUCT WAS REPORTED IN ERROR. NO PATIENT DEATH, SERIOUS INJURY OR EVIDENCE OF REPORTABLE PRODUCT MALFUNCTION OCCURRED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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

    DPS JOINT PRODUCT CODE/REF NOT THE SAME ON PRODUCT PACKAGE AS IT IS ON THE J&J OFFICIAL DOCUMENTS (DITCPATCHNOTE, INVOICE, ORDER CONFIRMATION). SO REF WHAT YOU CAN READ ON THE PACKAGE IS NOT THE SAME WHAT YOU GET FROM BARCODE. JNJ IS USING CODES INTERNALLY WITHOUT SPECIAL CHARACTERS. JNJ ITEM CODE DATABASE IS WITHOUT SPECIAL CHARACTERS, EXAMPLE REF 96-0101 IS IN READABLE FORMAT ON PACKAGE AND IN JDE&BARCODE IN FORMAT 960101.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687248 PFC*SIGMA/OV/DOME PAT 3PEG,35 SIGMA KNEE PRIMARY : KNEE PATELLA JWH DEPUY ORTHOPAEDICS INC US 96-0101 10603295232612

    Patients

    Seq Age Sex Outcome Treatment
    1