BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 4242378 · Received November 11, 2014

    Report

    Report Number
    1818910-2014-31511
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    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.(B)(4).

    Additional Manufacturer Narrative · 1

    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

    ADDITIONAL NARRATIVE: 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

    (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS HIGH COBALT CHROME LEVEL OF 197.5 AND CLICKING.

    Description of Event or Problem · 1

    UPDATE REC'D 3/7/2016: LITIGATION RECEIVED. LITIGATION ALSO ALLEGES PAIN AND DISCOMFORT. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING INVESTIGATION. THIS COMPLAINT WAS UPDATED ON: 3/22/2016.

    Description of Event or Problem · 1

    PPF ALLEGES METAL WEAR AND METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727392 ARTICULEZE M HEAD 36MM +1.5 HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 2833435

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention