BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE BALL 28 +5 BR

    MDR report key: 2071509 · Received April 15, 2011

    Report

    Report Number
    1818910-2011-06657
    Event Type
    Injury
    Date Received
    April 15, 2011
    Report Date
    March 16, 2011
    Manufacturer
    DEPUY SUZHOU
    Product Code
    JDI
    PMA / PMN Number
    K883460
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS ONE ADDITIONAL REPORT AGAINST THE SELF CENTERING HIP COMPONENT, LOT C57E51. THE DEVICE HISTORY RECORD WAS REVIEWED WITH NO RELATED DEVIATIONS OR ANOMALIES FOUND. NO OTHER REPORTED INCIDENTS AGAINST WERE IDENTIFIED AGAINST THE ASSOCIATED FEMORAL HEAD OR STEM 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

    PRELIMINARY DISCLOSURE FORM WAS RECEIVED. PATIENT DID NOT HAVE ASR AS WAS ORIGINALLY REPORTED BY THEIR ATTORNEY, BUT A SELF-CENTERING HIP. COMPLAINT HAS BEEN REOPENED TO UPDATE PRODUCTS. THIS COMPLAINT IS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4).DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION 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 AFTER SURGERY, PATIENT SUFFERED SYMPTOMS AND DAMAGE TO HER BODY INCLUDING BUT NOT LIMITED TO SEVERE PAIN AND DISCOMFORT IN HER GROIN, THIGH, AND HIP; CLICKING, GRINDING AND POPPING OF THE IMPLANT WHEN SHE WALKED AND WENT TO AND FROM A SITTING POSITION; INFECTION AND INFLAMMATION OF BONE AND TISSUE SURROUNDING THE IMPLANT; METALLOSIS; LACK OF MOBILITY; AND CHROMIUM AND COBALT METAL TOXICITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE BALL 28 +5 BR FEMORAL HEAD JDI DEPUY SUZHOU NA D08110419

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention