BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML SM STATURE 15.0MM

    MDR report key: 3914505 · Received July 3, 2014

    Report

    Report Number
    1818910-2014-22700
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    May 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK012364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. 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. 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

    LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN AND DIFFICULTY AMBULATING. COMMENT: DUE TO LITIGATION DISCUSSING THE ISSUES OF METAL-ON-METAL, WE ARE CURRENTLY REPORTING THE METAL LINER AND FEMORAL HEAD. SHOULD WE RECEIVE ADDITIONAL INFORMATION, WE WILL UPDATE ACCORDINGLY. UPDATE REC'D (B)(6) 2014 - PFS AND MEDICAL RECORDS RECEIVED. PART/LOT INFORMATION RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: (B)(6) 2014. UPDATE REC'D (B)(6) 2014 - PFS AND MEDICAL RECORDS RECEIVED. PART/LOT INFORMATION RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS IT SHOWED THE PATIENT WAS ACTUALLY IMPLANTED WITH A POLY LINER. SINCE LITIGATION ALLEGED PAIN AND DIFFICULTY WALKING, ALL IMPLANTS ARE NOW BEING ADDED TO THE COMPLAINT AS NONE OF THEM CAN BE EXCLUDED AT THE CAUSE OF PAIN. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. IT SHOULD BE NOTED THE OPERATIVE NOTE WAS PROVIDED, BUT WAS OF VERY POOR QUALITY. THE COMPLAINT WAS UPDATED ON: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389806 AML SM STATURE 15.0MM HIP FEMORAL STEM/SLEEVE JDI DEPUY ORTHOPAEDICS INC US E5PA41000

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other