BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE BALL 28 +1.5 GR

    MDR report key: 2002201 · Received February 18, 2011

    Report

    Report Number
    1818910-2011-02555
    Event Type
    Injury
    Date Received
    February 18, 2011
    Report Date
    January 19, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    JDI
    PMA / PMN Number
    K883460
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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 OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT DURING THE PATIENT'S RECOVERY, IT WAS DISCOVERED THAT THE RIGHT LEG WAS NOW SHORTER THAN HER LEFT LEG. PLAINTIFF INCREASINGLY EXPERIENCED DEBILITATING PAIN. IT WAS FURTHER ALLEGED THAT IT WAS DISCOVERED THAT THE HIP REPLACEMENT SYSTEM HAD COLLAPSED, AND THAT METAL SHAVINGS SHEARING OFF THE DEPUY FEMORAL HEAD HAD CAUSED TISSUE AND BONE DAMAGE. THE METAL SHAVINGS ALSO HAD CAUSED AN INFLAMMATORY REACTION IN THE PATIENT'S BODY, RESULTING IN DEATH OF TISSUE AND LOSS OF SURROUNDING BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICUL/EZE BALL 28 +1.5 GR 87JDI JDI DEPUY INTERNATIONAL, LTD. NA 2763380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention