BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRX NEUT 36IDX54OD

    MDR report key: 3914300 · Received July 3, 2014

    Report

    Report Number
    1818910-2014-22679
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    PMA / PMN Number
    PK102423
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    ONE OF THE ARDS PREVENTED THE LINER FROM SEATING. SURGEON INSPECTED THE ARDS AND SAW ONE WAS DEFECTIVE. OPENED SECOND LINER, AND IT SEATED PROPERLY. DATE OF SURGERY: (B)(6) 2014. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. 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

    ONE OF THE ARDS PREVENTED THE LINER FROM SEATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389759 ALTRX NEUT 36IDX54OD HIP ACETABULAR INSERT/LINER LPH DEPUY ORTHOPAEDICS, INC. 1818910 435358

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR