BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML HIGH OFFSET LG STAT 15.0MM

    MDR report key: 4850602 · Received June 17, 2015

    Report

    Report Number
    1818910-2015-23812
    Event Type
    Injury
    Date Received
    June 17, 2015
    Date of Event
    July 26, 2012
    Report Date
    May 20, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK012364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    ADDITIONAL NARRATIVE: 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

    UDI: (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN. UPDATE 5/20/15-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED PAIN , PSEUDOTUMOR, AND METAL ON METAL HYPERSENSITIVITY. THE STEM IS BEING ADDED FOR THE ALLEGED HIGH METAL IONS-NO LAB PROVIDED. LOT NUMBERS ARE BEING UPDATED. THE COMPLAINT WAS UPDATED ON: 6/17/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395060 AML HIGH OFFSET LG STAT 15.0MM HIP FEMORAL STEM/SLEEVE JDI DEPUY ORTHOPAEDICS INC US A87DY1000

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention