BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON 10D 54OD X 28ID

    MDR report key: 1895172 · Received November 8, 2010

    Report

    Report Number
    1818910-2010-08408
    Event Type
    Injury
    Date Received
    November 8, 2010
    Date of Event
    May 17, 2010
    Report Date
    November 1, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K944538
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    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 CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE THAT THE PT WAS IMPLANTED WITH DEPUY PRODUCTS ON THE LEFT HIP (NON-ASR); HOWEVER, DO NOT PROVIDE THE REASON FOR REVISION. (B)(6) . A PROGRESS NOTE DATED (B)(6) 2004 INDICATED THAT X-RAYS SHOWED EVIDENCE OF POLY WEAR AND THE SURGEON NOTED THAT THE PT WOULD LIKELY NEED REVISION SURGERY. IT IS REASONABLE TO CONCLUDE THAT PT'S REPORTED REVISION OF (B)(6) 2005 WAS DUE TO POLY WEAR GIVEN THE SURGEON'S MEMO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURON 10D 54OD X 28ID 87HRY LPH DEPUY ORTHOPAEDICS, INC. NA 730750008

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention