BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON 10D 52OD X 32ID

    MDR report key: 2213387 · Received August 12, 2011

    Report

    Report Number
    1818910-2011-14663
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K944538
    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. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS 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

    THE PATIENT PRESENTED AT THE HOSPITAL HAVING DISLOCATED. CLOSED REDUCTION FAILED AND THE PATIENT WAS REVISED. POLY WEAR NOTED INTRA-OPERATIVELY. APPROX 13 YEARS AGO - DOR: (B)(6) 2011 (RIGHT SIDE).

    Description of Event or Problem · 1

    PT WAS REVISED POLYWEAR AND DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURON 10D 52OD X 32ID HRY, HSX, JDB, JDI, JWH, KWA, KWT LPH DEPUY ORTHOPAEDICS, INC. NA RG1KS1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention