BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIN TRL LNR +4 10D 52ODX32ID

    MDR report key: 7171628 · Received January 8, 2018

    Report

    Report Number
    1818910-2018-50496
    Event Type
    Malfunction
    Date Received
    January 8, 2018
    Date of Event
    December 11, 2017
    Report Date
    December 12, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS INC 1818910
    Product Code
    LXH
    UDI-DI
    10603295100836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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) INVESTIGATION SUMMARY: THE INSTRUMENT ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE PROVIDED PHOTOGRAPH CONFIRMED THE REPORTED OBSERVATION. 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.

    Description of Event or Problem · 1

    (B)(6) HOSPITAL, (B)(6) 2017. PINNACLE TRIAL LINER 32 +4/10DEG 52MM. CONSIGNMENT INSTRUMENT AT GPH, IN A DAMAGED CONDITION. PHOTO INDICATED BURRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16262 PIN TRL LNR +4 10D 52ODX32ID HIP INSTRUMENTS : ACETABULAR TRIALS LXH DEPUY ORTHOPAEDICS INC 1818910 CY0504 10603295100836

    Patients

    Seq Age Sex Outcome Treatment
    1