BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE BALL 32 +1 GR

    MDR report key: 4398096 · Received January 8, 2015

    Report

    Report Number
    1818910-2015-10558
    Event Type
    Injury
    Date Received
    January 8, 2015
    Date of Event
    March 11, 2013
    Report Date
    April 1, 2015
    Manufacturer
    3003895575 DEPUY FRANCE S.A.S
    Product Code
    JDI
    PMA / PMN Number
    PK843909
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: UNAVAILABLE. THIS COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). THIS COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT SUFFERS FROM TOXIC COBALT-CHROMIUM METAL IONS, PAIN, DISCOMFORT, AND DISLOCATION.

    Description of Event or Problem · 1

    ANALYST FOUND LOT NUMBER FOR THE FEMORAL HEAD-LOT NUMBER IS BEING UPDATED.

    Description of Event or Problem · 1

    UPDATE 2/11/15 - PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED INSTABILITY, DISLOCATION, AND COMPRESSION OF THE LINER ALONG THE POSTERIOR/SUPERIOR ASPECT. THE CUP WAS REVISED DURING THE REVISION, BUT THERE WAS NO MENTION OF LOOSENING/MALPOSITIONING. IT SHOULD BE NOTED THE PATIENT HAD A POLY LINER IMPLANTED DURING THE PRIMARY OPERATION. NO LABS WERE PROVIDED FOR THE ALLEGED HIGH METAL IONS. THE COMPLAINT WAS UPDATED ON 3/4/2015 THE LOT NUMBER PROVIDED FOR THE FEMORAL HEAD IS INVALID AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14797 ARTICUL/EZE BALL 32 +1 GR HIP FEMORAL HEAD JDI 3003895575 DEPUY FRANCE S.A.S D12060605

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention