BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCS HP BALANCING TRAY

    MDR report key: 7577591 · Received June 7, 2018

    Report

    Report Number
    1818910-2018-61571
    Event Type
    Malfunction
    Date Received
    June 7, 2018
    Date of Event
    January 1, 2018
    Report Date
    May 14, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910 
    Product Code
    FSM
    UDI-DI
    10603295229858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED EVENT. 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

    INVESTIGATION SUMMARY : EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED EVENT. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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

    INSTRUMENT PAN IS PEELING AND NEEDS TO BE REPLACED. NOTHING FELL INTO PATIENT. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY. ONE IMPACTED, ONE NEEDING REPLACEMENT NO CHARGE REPLACEMENT PO#(B)(4). SOLD TO 0010202068. SHIP TO 0010203264 SHC. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420590 LCS HP BALANCING TRAY KNEE INSTRUMENT : INSTRUMENT CASES FSM DEPUY ORTHOPAEDICS, INC. 1818910  PG2461607 10603295229858

    Patients

    Seq Age Sex Outcome Treatment
    1