BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APG+ CURVED HANDLE

    MDR report key: 7116699 · Received December 14, 2017

    Report

    Report Number
    1818910-2017-51638
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    November 14, 2017
    Report Date
    November 14, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    UDI-DI
    10603295102960
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (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. 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

    (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

    IT WAS REPORTED THAT THE 48 SIZING DISK IS NOT CONNECTING PROPERLY TO HANDLE. MAY BE DUE TO WEAR. NO SURGICAL DELAY; DOE: (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897387 APG+ CURVED HANDLE SHOULDER INSTRUMENT LXH DEPUY ORTHOPAEDICS, INC. 1818910 PG0310 10603295102960

    Patients

    Seq Age Sex Outcome Treatment
    1