BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +8.5

    MDR report key: 6251521 · Received January 13, 2017

    Report

    Report Number
    1818910-2017-10866
    Event Type
    Injury
    Date Received
    January 13, 2017
    Date of Event
    December 20, 2016
    Report Date
    December 20, 2016
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8080379
    Product Code
    JDI
    PMA / PMN Number
    K082585
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THESE COMPLICATIONS OF JOINT REPLACEMENT ARE 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. UDI: (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THIS COMPLAINT IS FOR THE RIGHT HIP. A CORRECT DOI AND DOR WERE PROVIDED. THE MEDICAL RECORDS INDICATED THE PATIENT EXPERIENCED SEVERAL DISLOCATIONS, PAIN, INSTABILITY, LEG LENGTH DISCREPANCY, AND CLUNKING SOUND. THE CUP WAS NOTED TO BE MALPOSITIONED AT REVISION. ITS REASONABLE TO CONCLUDE THE CLUNKING SOUND WAS A RESULT OF THE REPEATED DISLOCATIONS AND MALPOSITIONED CUP. THE CUP IS BEING ADDED TO THE COMPLAINT.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO ADDRESS MULTIPLE DISLOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34101 ARTICULEZE M HEAD 36MM +8.5 HIP FEMORAL HEAD JDI DEPUY INTERNATIONAL LTD. 8080379 2982946

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention