BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +5

    MDR report key: 2883164 · Received December 21, 2012

    Report

    Report Number
    1818910-2012-22984
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    July 16, 2009
    Report Date
    November 26, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    **UPDATE** 8/31/2012- LITIGATION PAPERS RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THE INVESTIGATION. **UPDATE** 11/29/2012 - MEDICAL RECORDS WERE RECEIVED. THE PRIMARY OPERATIVE REPORT INDICATED THAT SMALL CRACKS WERE NOTED IN THE PROXIMAL FEMUR AFTER REMOVAL OF THE FEMORAL TRIAL; HOWEVER, THERE WAS NO FURTHER ISSUE NOTED AS A RESULT OF THIS. RECORDS ARE AVAILABLE ON EXTERNAL HARD DRIVE IF NEEDED FOR FURTHER REVIEW. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE REPORTED PART AND LOT CODE 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 A ROOT CAUSE CORRECTIVE ACTION WAS NOT ESTABLISHED. 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

    **UPDATE** (B)(6) 2012- LITIGATION PAPERS RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. **UPDATE**(B)(6) 2012-MEDICAL RECORDS WERE RECEIVED AND AVAILABLE ON A DISC. MEDICAL RECORDS INDICATED A SIGNIFICANT NOTCH IN THE FEMORAL NECK AGAIST THE ACETABULAR LINER WAS CUTTING INTO AND THIS INVOLVED APPROXIMATLEY 50% OF THE WIDTH OF THE TRUNNION OF THE STEM. THE FEMORAL HEAD WAS COLD WELDED ON TO THE TRUNNION OF THE STEM. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE REPORTED PART AND LOT CODE 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 A ROOT CAUSE CORRECTIVE ACTION WAS NOT ESTABLISHED. 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)(6).

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS DISASSOCIATION OF THE METAL LINER FROM THE CUP. A HOLE HAD BEEN WORN THROUGH THE CUP. METALLOSIS WAS ALSO FOUND. **UPDATE** (B)(6) 2012- LITIGATION PAPERS RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. **UPDATE** (B)(6) 2012-MEDICAL RECORDS WERE RECEIVED AND AVAILABLE ON A DISC. MEDICAL RECORDS INDICATED A SIGNIFICANT NOTCH IN THE FEMORAL NECK AGAINST THE ACETABULAR LINER WAS CUTTING INTO AND THIS INVOLVED APPROXIMATELY 50% OF THE WIDTH OF THE TRUNNION OF THE STEM. THE FEMORAL HEAD WAS COLD WELDED ON TO THE TRUNNION OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE M HEAD 36MM +5 TOTAL HIP REPLACEMENT JDI DEPUY ORTHOPAEDICS, INC. 1818910 1168388

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention