BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12/14 ARTICUL 40 MM M SPEC+8.5

    MDR report key: 4233566 · Received November 6, 2014

    Report

    Report Number
    1818910-2014-31371
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 17, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K060031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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

    ADDITIONAL NARRATIVE: (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

    (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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

    UPDATE 01/11/17 ¿ PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS NOTED WITHIN THE REVISION OPERATIVE INDICATIONS THAT THE PATIENT HAD PAIN AND ELEVATED COBALT AND CHROMIUM LEVELS. WITHIN THE GROSS FINDINGS, THE SURGEON NOTED THAT THERE WAS "STAINING OF THE SOFT TISSUE, CONSISTENT WITH METALLOSIS", BUT ALSO NOTED THAT THERE WAS "NO PSEUDOTUMOR." ALSO NOTED THAT "IT APPEARED THAT THE STEM HAD SUBSIDED SOMEWHAT DURING HEALING' FOLLOWING RECOVERY FROM HIS PRIMARY SURGERY. NO METAL ION LAB VALUES AVAILABLE TO REFERENCE. STEM ADDED TO COMPLAINT. ELEVATED METAL IONS, METALLOSIS, AND STEM SUBSIDENCE/IMPLANT MIGRATION HARMS ADDED TO COMPLAINT AND MEDWATCHES. PART/LOT UPDATED. DEMOGRAPHICS UPDATED. CORRECTED DOI AND ADDED DOR.

    Description of Event or Problem · 1

    LITIGATION ALLEGES, THE PATIENT SUFFERS FROM PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715278 12/14 ARTICUL 40 MM M SPEC+8.5 HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 2457555

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other