BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR NEUT 50ODX28ID

    MDR report key: 3201855 · Received July 2, 2013

    Report

    Report Number
    1818910-2013-20380
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 16, 2013
    Report Date
    June 25, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC
    Product Code
    LPH
    PMA / PMN Number
    PK000306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICES FINDS EVIDENCE TO SUPPORT DISASSOCIATION OF THE LINER AND CUP WHILE IMPLANTED. IN THIS CASE ONE OF THE ARD'S OF THE POLYETHYLENE LINER HAS FRACTURED, TWO OTHER ARD'S SHOW SIGNS OF DAMAGE. THERE ARE MACHINING LINES YET VISIBLE WITHIN THE INNER RADIUS OF THE LINER WHICH WOULD NOT BE AS OBVIOUSLY PRESENT HAD THE FEMORAL HEAD BEEN MORE CENTRALLY LOADED. THE EDGE LOADING OF THE LINER HAS PLACED PRESSURES ON THE MATERIAL NEAR THE RIM THAT WERE NOT INTENDED AND THE POSSIBLY CONTRIBUTED TO THE SUBSEQUENT DISASSOCIATION OF THE LINER FROM THE CUP. THE EDGE LOADING CONDITION IS CONFIRMED THROUGH REVIEW OF PROVIDED PATIENT X-RAYS. THE PATIENT IS A REPORTED (B)(6) YEAR OLD MALE WITH A CALCULATED BMI OF 29.4. ACTIVITY LEVEL WAS NOT PROVIDED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT/LOT CODE COMBINATION OF THE INSERT SINCE ITS RELEASE TO DISTRIBUTION. ADDITIONALLY, RESEARCH USING THE AS400 SYSTEM INDICATES THAT SEVERAL PIECES FROM THE REPORTED LOT HAVE BEEN DELIVERED, AND, AS NO ADDITIONAL REPORTS HAVE BEEN RECEIVED, CAN BE REASONABLY ASSUMED IMPLANTED WITHOUT ISSUE. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION 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

    LUXATION OF THE POLYETHYLENE INLAY REVISION SURGERY WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302125 PINN MAR NEUT 50ODX28ID ACETABULAR LINER LPH DEPUY ORTHOPAEDICS INC 364658

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention