BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE BALL 32 + 1 GR

    MDR report key: 1220481 · Received November 3, 2008

    Report

    Report Number
    1818910-2008-05018
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 17, 2008
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    JDI
    PMA / PMN Number
    K883460
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. REVIEW OF THE RETRIEVED DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR/CONTRIBUTION REGARDING THE REPORTED PROBLEM. 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

    PATIENT WAS REVISED TO ADDRESS DISLOCATION. IT WAS REPORTED THAT THE PATIENT FELL APPROXIMATELY 4-5 MONTHS AFTER PRIMARY SURGERY AND DISLOCATED AT THAT POINT. SHE HAS EXPERIENCED A FEW DISLOCATIONS SINCE THEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICUL/EZE BALL 32 + 1 GR 87JDI JDI DEPUY INTERNATIONAL, LTD. NA 2492251

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention