BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12/14 ARTICUL 40MM M SPEC+12

    MDR report key: 3063398 · Received April 17, 2013

    Report

    Report Number
    1818910-2013-15480
    Event Type
    Injury
    Date Received
    April 17, 2013
    Report Date
    February 10, 2017
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    JDI
    PMA / PMN Number
    K060031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    ADDITIONAL NARRATIVE: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PAIN, LOOSENING, AND METALLOSIS.

    Description of Event or Problem · 1

    UPDATE (B)(6) 2017 ¿PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, REVISED (B)(6) 2014 TO ADDRESS PAIN. DURING THE PROCEDURE THE SURGEON REPORTED WELL POSITIONED AND FIXED STEM, HYPERTROPHIC INFLAMED BURSA, THE ACETABULAR COMPONENT WAS WELL-FIXED BUT MALPOSITIONED WITH TOO MUCH ANTEVERSION AND THE PATIENT HAD RETRO-ACETABULAR OSTEOLYSIS. MEDICAL RECORDS REPORT HEARING LOSS AND ELEVATED METAL ION LEVELS. CHANGING THE PREVIOUSLY REPORTED UNK PRODUCT TO A CUP. PART/LOT NUMBERS PROVIDED FOR HEAD/LINER. METAL ION LEVELS PROVIDED WERE AT NON-REPORTABLE LEVELS. THE COMPLAINT WAS UPDATED ON: (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165827 12/14 ARTICUL 40MM M SPEC+12 HIP FEMORAL HEAD JDI DEPUY INTERNATIONAL LTD. 8010379 2421352

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other