BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFCSIG INS TRL CURVED 8MM SZ3

    MDR report key: 9689238 · Received February 10, 2020

    Report

    Report Number
    1818910-2020-04416
    Event Type
    Malfunction
    Date Received
    February 10, 2020
    Date of Event
    January 29, 2020
    Report Date
    January 29, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LXH
    UDI-DI
    10603295237228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10 ADDITIONAL NARRATIVE: CORRECTED: H6 PRODUCT COMPLAINT # ==> PC-(B)(4). INVESTIGATION SUMMARY ==> NO DEVICE WAS RECEIVED FOR EXAMINATION, THEREFORE THE REPORTED EVENT COULD NOT BE CONFIRMED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT ==> NULL. DEVICE HISTORY BATCH ==> NULL. DEVICE HISTORY REVIEW ==> NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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

    THE TRIAL LINER(#961350) DOES NOT CLIP WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153295 PFCSIG INS TRL CURVED 8MM SZ3 KNEE INSTRUMENT : TIBIAL TRIALS LXH DEPUY ORTHOPAEDICS INC US 96-1350 10603295237228

    Patients

    Seq Age Sex Outcome Treatment
    1