BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUR MAR 10D LINER 28IDX56OD

    MDR report key: 1822521 · Received August 27, 2010

    Report

    Report Number
    1818910-2010-06130
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 29, 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
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICES AND PATIENT X-RAYS BY DEPUY INTERNATIONAL DID NOT REVEAL ANY RELATED PRODUCT PROBLEMS, MANUFACTURING DEVIATIONS OR ANOMALIES. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. THE INVESTIGATION CAN DRAW NO CONCLUSIONS REGARDING THE REPORTED EVENT. ALTHOUGH, INVESTIGATION FINDS IT MAY BE THAT THE PATIENT WEIGHT WAS A CONTRIBUTORY FACTOR. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. MONITOR THROUGH TREND ANALYSIS.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

    REVISED FOR POLYETHYLENE WEAR AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUR MAR 10D LINER 28IDX56OD LPH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention