BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUR MAR NEUT LINER 28IDX58OD

    MDR report key: 1812429 · Received August 16, 2010

    Report

    Report Number
    1818910-2010-05549
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 20, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K994415
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID TO SHOW ANY OTHER REPORTS AGAINST THE PROVIDED PRODUCT/LOT CODE COMBINATIONS FOR THE DUR MAR NEUT LINER (B)(4) AND THE LUSTER HIP SZ 1 HIGH OFFSET. THE LOT CODE REQUIRED FOR A LOT SPECIFIC SEARCH OF THE COMPLAINT DATABASE WAS NOT SUPPLIED FOR THE DEPUY CMW 3 40G. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITH THE PROVIDED INFORMATION. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THE TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT THE CEMENT/IMPLANT INTERFACE (DEPUY CEMENT WAS USED IN THE PRIMARY SURGERY). POLY WEAR OF THE LINER AND OSTEOLYSIS WERE ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUR MAR NEUT LINER 28IDX58OD 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA FJVR

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention