BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIN TRL LNR NEUT +4 40ID 56OD

    MDR report key: 5032097 · Received August 26, 2015

    Report

    Report Number
    1818910-2015-29032
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Date of Event
    July 28, 2015
    Report Date
    July 28, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED WAS NOT PROVIDED. PREVIOUS INVESTIGATIONS FOUND THE USER OVER-TIGHTENING THE THREADED INSERT DURING USE AND INTENTIONALLY DISASSEMBLING THE SNAP RING FROM THE SCREW FOR SURGICAL PREFERENCE OR CLEANING ARE SUSPECTED ROOT CAUSES. (B)(4) WAS CONDUCTED IN NOVEMBER OF 2011. THE INVESTIGATION DID NOT ESTABLISH THE NEED FOR CORRECTIVE ACTION BASED ON NO IMMEDIATE PATIENT RISK, THE LOW FREQUENCY OF REPORTED EVENTS, AND SUSPECTED CUSTOMER MISUSE AS THE ROOT CAUSE. NO EVIDENCE WAS FOUND OF PRODUCT OR DESIGN ERROR AS A CONTRIBUTING FACTOR. ALL SUBSEQUENT COMPLAINTS REGARDING FAILURES WITHIN THE PINNACLE TRIAL LINER PRODUCT FAMILY WILL BE MONITORED UNDER POST MARKET SURVEILLANCE SEP 419. 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

    WHILE TRIALING THE LINER, THE MIDDLE SCREW SNAPPED OFF WHERE THE SCREW IS HELD ON BY THE PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564560 PIN TRL LNR NEUT +4 40ID 56OD HIP INSTRUMENT/TRIAL LHX DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR