BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTIMA POLY 52MM CUP, NON-CAPT

    MDR report key: 1895098 · Received November 5, 2010

    Report

    Report Number
    1818910-2010-07697
    Event Type
    Injury
    Date Received
    November 5, 2010
    Report Date
    October 7, 2010
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    JDI
    PMA / PMN Number
    K924115
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    OTHER

    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

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY ADDITIONAL REPORTS AGAINST THE PRODUCT LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    ACETABULAR LOOSENING NOTED IN EARLY 2010. CURRENTLY, AWAITING FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIMA POLY 52MM CUP, NON-CAPT 87 JDI JDI DEPUY INTL., LTD. NA 2836907

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention