BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 3822523 · Received May 21, 2014

    Report

    Report Number
    1818910-2014-19183
    Event Type
    Injury
    Date Received
    May 21, 2014
    Report Date
    December 11, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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. ADDITIONAL NARRATIVE: 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

    LITIGATION PAPERS ALLEGE: PAIN AND DISCOMFORT, INTERFERENCE WITH HER ACTIVITIES OF DAILY LIVING AND OTHER PROBLEMS. ON (B)(6) 2011, BLOOD TEST WERE ORDERED THE RESULTS ARE AS FOLLOWS: CHROMIUM 3.1 H COBALT 7.0 H. SHE WILL NEED TO HAVE A BILATERAL REVISION SURGERY IN THE FUTURE. UPDATE REC'D (B)(4) 2012 - PFS AND MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED. PATIENT ALLEGES HIGH METAL IONS SO THE TWO UNKNOWN DEPUY PENNICLE HIPS ARE BEING CHANGED TO A METAL LINER AND HEAD FOR THE LEFT IMPLANTS. ANOTHER LINER AND HEAD ARE BEING ADDED FOR THE RIGHT PRIMARY IMPLANTS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303775 ARTICULEZE M HEAD 36MM +1.5 HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 1882930

    Patients

    Seq Age Sex Outcome Treatment
    1 Other