BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON 10D 62 OR 74ODX32ID

    MDR report key: 1983447 · Received January 31, 2011

    Report

    Report Number
    1818910-2011-00097
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 5, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDL
    PMA / PMN Number
    K900832
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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.

    Additional Manufacturer Narrative · 1

    JOHNSON AND JOHNSON MEDICAL (B)(4) REPORTS: REVISION RIGHT AML / DURALOC TOTAL HIP REPLACEMENT. PRIMARY SURGERY IN 1993 AT (B)(6) HOSPITAL. LINER/ DURALOC SCREW 35MM AND HEAD REMOVED. CUP REMAINED SECURE INSITU, NEW SCREWS 6.5 MM INSERTED LENGTHS 30 MM AND 40 MM ALSO 62MM LOCKING RING AND DURALOC MARATHON LINER 32MMID 10 DEGREE LIPPED INSERTED. A 32MM HEAD +0. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PRODUCT AND LOT COMBINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. 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 AND / OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURON 10D 62 OR 74ODX32ID 87JDL JDL DEPUY ORTHOPAEDICS, INC. NA 559830042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention