BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON NEUT 56 OR 68ODX28ID

    MDR report key: 1201457 · Received October 16, 2008

    Report

    Report Number
    1818910-2008-04615
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 23, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HRY
    PMA / PMN Number
    K944538
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS UNABLE TO VERIFY OR DRAW ANY CONCLUSIONS REGARDING THE REPORTED OSTEOLYSIS WITH THE INFORMATION AVAILABLE. EXAMINATION OF THE RETURNED ITEMS AND REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED PRODUCT PROBLEMS, MANUFACTURING DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR/CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PATIENT REVISED TO ADDRESS OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURON NEUT 56 OR 68ODX28ID 87HRY HRY DEPUY ORTHOPAEDICS, INC. NA S3HBE1

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention