BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +8.5

    MDR report key: 3943812 · Received July 18, 2014

    Report

    Report Number
    1818910-2014-23762
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 25, 2012
    Report Date
    June 20, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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

    THE COMPLAINT WAS REOPENED UPON RECEIVING PATIENT MEDICAL RECORDS INCLUDING X-RAYS. THE X-RAYS WERE REVIEWED FOR IMPLANT DISASSOCIATION AND IMPLANT FRACTURE AS PER WI-7915. NO ANOMALIES WERE NOTED (B)(4). THERE WERE NO FURTHER CHANGES TO THE ORIGINAL INVESTIGATION REPORT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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

    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.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM (B)(6). FORMAL CLAIM RECEIVED REGARDING PINNACLE/CORAIL HIP IMPLANT REVISION. REASON FOR REVISION CONFIRMED AS PAIN. FINDINGS DURING REVISION INCLUDE LARGE METAL STAINED EFFUSION, SIGNIFICANT SOLID PSEUDOTUMOUR AND METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422053 ARTICULEZE M HEAD 36MM +8.5 HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS, INC.1818910 2077268

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other