BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIN TRL LNR NEUT +4 40ID 58OD

    MDR report key: 3864155 · Received June 10, 2014

    Report

    Report Number
    1818910-2014-20587
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE INITIAL REPORT STATED THE DEVICE WOULD NOT BE RETURNED. A COMPLAINT DATABASE SEARCH ON THE PROVIDED PRODUCT CODE IDENTIFIED SIMILAR REPORTS.THE USER INADVERTENTLY OVER-TIGHTENING THE THREADED INSERT DURING USE IS SUSPECTED TO BE THE ROOT CAUSE. A PRELIMINARY RISK ASSESSMENT AND HEALTH HAZARD EVALUATION WAS PREVIOUSLY CONDUCTED FOR THIS FAILURE. THAT 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. CORRECTIVE ACTION NOT INDICATED AT THIS TIME. CONTINUE TO MONITOR THROUGH TREND ANALYSIS.DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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

    THE RETAINING CLIP FOR THE LINER WAS NOT ATTACHED TO THE TRIAL UPON CLEANING OF INSTRUMENTS. SURGEON WAS NOTIFIED WHILE CLOSING PATIENT. X-RAYS WERE DONE AND FOUND NOT TO BE IN WOUND, BUT THIS CAUSED A ONE HOUR DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338431 PIN TRL LNR NEUT +4 40ID 58OD HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. 1818910 PG1109

    Patients

    Seq Age Sex Outcome Treatment
    1 Other