BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12/14 ARTICUL 48MM M SPEC+15.5

    MDR report key: 4233555 · Received November 6, 2014

    Report

    Report Number
    1818910-2014-31369
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 17, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: UNAVAILABLE. SEE SECTION D FOR ANY PRODUCT INFORMATION RECEIVED. THIS COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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

    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 AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    UPDATE¿ PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE PFS AND MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT DOES NOT ALLEGE IN THE PFS, NOR DOES THE MEDICAL RECORD INDICATE THE PRESENCE OF PAIN IN THE RIGHT HIP. THERE IS NO DISCUSSION WITHIN THE MEDICAL RECORD ABOUT THE NEED TO REVISE THE RIGHT HIP. THE REVISING SURGEON FOR PATIENT'S LEFT HIP ((B)(6) 2011) DID INDICATE THE PRESENCE OF ELEVATED METAL IONS, BUT NO METAL ION LAB VALUES ARE AVAILABLE TO REVIEW. BECAUSE THE RECORD DOES NOT INDICATE ANY PROBLEMS WITH THE RIGHT HIP SPECIFICALLY, THE STEM WILL NOT BE ADDED TO THE COMPLAINT AT THIS TIME. PATIENT HARM CHANGED TO ASYMPTOMATIC. PROD/LOT UPDATED FOR PREVIOUSLY REPORTED PRODUCTS.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715802 12/14 ARTICUL 48MM M SPEC+15.5 HIP FEMORAL HEAD JDI DEPUY INTERNATIONAL LTD. 8010379 1934792

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other