BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETAINING STEM INSERTER

    MDR report key: 3924724 · Received July 10, 2014

    Report

    Report Number
    1818910-2014-23077
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.

    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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED PRODUCTS CONFIRMS THE THREADS ARE NICKED AND DAMAGED. THE CAUSE IS ATTRIBUTED TO MISUSE AND HEAVY USAGE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED

    Description of Event or Problem · 1

    THREADED IMPACTOR WOULD NOT THREAD ONTO HIP STEM. IMPACTOR THREADS ARE STRIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403595 RETAINING STEM INSERTER HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. BO411

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR