BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCS HP BALANCING TRAY

    MDR report key: 7650043 · Received June 29, 2018

    Report

    Report Number
    1818910-2018-63485
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    January 1, 2018
    Report Date
    June 7, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910 
    Product Code
    FSM
    UDI-DI
    10603295229858
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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, 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.

    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

    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 (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
    493291 LCS HP BALANCING TRAY KNEE INSTRUMENT : INSTRUMENT CASES FSM DEPUY ORTHOPAEDICS, INC. 1818910  C51JK4 10603295229858

    Patients

    Seq Age Sex Outcome Treatment
    1