BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METAGLENE POSITIONER PLATE

    MDR report key: 7151589 · Received December 28, 2017

    Report

    Report Number
    1818910-2017-52652
    Event Type
    Malfunction
    Date Received
    December 28, 2017
    Date of Event
    December 4, 2017
    Report Date
    December 4, 2017
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    LXH
    UDI-DI
    10603295116448
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    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.

    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. PRODUCT COMPLAINT # PC-(B)(4). INVESTIGATION SUMMARY EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS PERFORMING A REVERSE SHOULDER ARTHROPLASTY WHEN PRODUCT DP-5219832 LOT 230787003 BECAME STUCK ON A GUIDE WIRE (230787004 LOT 5293483). SURGEON COULD NOT DISENGAGE THE TWO INSTRUMENTS. NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930574 METAGLENE POSITIONER PLATE EXTREMITY INSTRUMENTS : ALIGNMENT DEVICES LXH DEPUY FRANCE SAS - 3003895575 5219831 10603295116448

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR