BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUR MAR 10D LINER 28IDX50OD

    MDR report key: 2121929 · Received June 9, 2011

    Report

    Report Number
    1818910-2011-10155
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    LPH
    PMA / PMN Number
    K994415
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. PATIENT X-RAYS HAVE BEEN PROVIDED FOR EXAMINATION. THE DEVICES ARE NOT IN A DISLOCATED STATE IN ANY OF THE IMAGES PROVIDED. THE ACETABULAR CUP APPEARS POSITIONED WITH MORE VERSION AND ABDUCTION ANGLE THAN RECOMMENDED BY SURGICAL TECHNIQUE. THIS COULD HAVE BEEN A CONTRIBUTING FACTOR IN DISLOCATION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. PRODUCT ERROR NOT IDENTIFIED. 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 DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUR MAR 10D LINER 28IDX50OD 87LPH LPH DEPUY INTERNATIONAL, LTD. NA 3142247

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention