BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE 100 ACET CUP 54MM

    MDR report key: 3884293 · Received June 19, 2014

    Report

    Report Number
    1818910-2014-21535
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    October 21, 2013
    Report Date
    May 27, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. 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.

    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

    UDI: (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES THE PATIENT SUFFERS FROM LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE, PAIN, DISCOMFORT AND INFLAMMATION. UPDATE REC'D (B)(6) 2014 - PFS AND MEDICAL RECORDS RECEIVED. PART/LOT INFORMATION PROVIDED, BUT WASN¿T LEGIBLE. AF TER REVIEW OF THE MEDICAL RECORDS THE REVISION OPERATIVE NOTE INDICATED THE CUP WAS MALPOSITIONED AND REVISED. AN UNKNOWN CUP IS BEING ADDED TO THE COMPLAINT. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359887 PINNACLE 100 ACET CUP 54MM HIP ACETABULAR CUP JDI DEPUY ORTHOPAEDICS INC US DK2EW1000

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention