BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE BALL 32 +5 BR

    MDR report key: 4110801 · Received September 23, 2014

    Report

    Report Number
    1818910-2014-28638
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 8, 2011
    Report Date
    March 15, 2013
    Manufacturer
    DEPUY INTL., LTD. ¿ REG. # 8010379
    Product Code
    JDI
    PMA / PMN Number
    PK843909
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. 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.

    Description of Event or Problem · 1

    PPD AND MEDICAL RECORDS RECEIVED. THIS COMPLAINT IS LEGAL. PATIENT WAS REVISED AGAIN ON (B)(6) 2011 FOR PAIN AFTER A FALL. THE STEM, HEAD, AND LINER WERE REMOVED AND ANTIBIOTIC SPACERS WERE PLACED AND THEY PLAN TO DO IMPLANTATION AT A LATER DATE. PPD INCLUDED OPERATIVE DATES OF (B)(6) 2011 AND (B)(6) 2013-THERE ARE NO MEDICAL RECORDS TO SUPPORT THESE SURGICAL DATES AND IT IS UNKNOWN WAS PRODUCTS WERE IMPLANTED. WE WILL UPDATE AS NEEDED IF WE RECEIVE MORE MEDICAL RECORDS THAT SUPPORT THESE DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589613 ARTICUL/EZE BALL 32 +5 BR HIP FEMORAL HEAD JDI DEPUY INTL., LTD. ¿ REG. # 8010379 2431403

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention