BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE BALL 28 +1.5 GR

    MDR report key: 1122737 · Received August 15, 2008

    Report

    Report Number
    1818910-2008-03519
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 5, 2008
    Manufacturer
    DEPUY INTL, LTD.
    Product Code
    JDI
    PMA / PMN Number
    K883460
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE LOT CODES REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. ALTHOUGH UNAVAILABLE FOR EVAL, IT WOULD NOT BE UNREASONABLE TO EXPECT POLY MATERIAL WEAR AFTER APPROX 13 YRS OF IMPLANTATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION/ERROR WITH REGARD TO THE REPORTED EVENT WITH THE INFO AVAILABLE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO 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 MULTIPLE DISLOCATIONS (RIGHT SIDE). POLY WEAR WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICUL/EZE BALL 28 +1.5 GR 87JDI JDI DEPUY INTL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention