BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +12

    MDR report key: 4753214 · Received May 6, 2015

    Report

    Report Number
    1818910-2015-20174
    Event Type
    Injury
    Date Received
    May 6, 2015
    Date of Event
    May 1, 2012
    Report Date
    May 6, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD 8010379
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    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. (B)(4).

    Description of Event or Problem · 1

    PPD AND MEDICAL RECORDS RECEIVED. PPD AND MEDICAL RECORDS WERE RECEIVED ON 12/2/2013 WITH THE ALERT DATE OF (B)(6) 2013. THESE RECORDS WERE REVIEWED FOR MDR REPORTABILITY ON 5/6/2015. AFTER REVIEW OF THE RECORDS FOR MDR REPORTABILITY, THE PATIENT WAS REVISED ON (B)(6) 2012 FOR DISLOCATIONS, INSTABILITY, PSEUDOTUMORS, AND RETROVERTED CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297236 ARTICULEZE M HEAD 36MM +12 HIP FEMORAL HEAD JDI DEPUY INTERNATIONAL LTD 8010379 1956065

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention