BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX +4 NEUT 44IDX62OD

    MDR report key: 2232236 · Received August 18, 2011

    Report

    Report Number
    1818910-2011-15965
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K072963
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 SINCE ITS RELEASE FOR DISTRIBUTION. USING A CEMENT PRODUCT TO PLACE THIS DEVICE DIRECTLY INTO A PATIENTS ACETABULUM IS NOT RECOMMENDED USE. THE ROOT CAUSE IS ATTRIBUTED TO USE ERROR. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS LOOSENING OF THE POLY LINER, WHICH HAD BEEN CEMENTED INTO THE ACETABULUM. THE LOOSENING OCCURRED AT THE CEMENT/IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED IN THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRX +4 NEUT 44IDX62OD 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA EA8F51000

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention