BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM STM STD 36+12L 13X18

    MDR report key: 6977708 · Received October 25, 2017

    Report

    Report Number
    1818910-2017-27450
    Event Type
    Injury
    Date Received
    October 25, 2017
    Date of Event
    December 2, 2015
    Report Date
    September 27, 2017
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    JDI
    PMA / PMN Number
    K851422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT # : (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. DEVICE HISTORY LOT : 3180077, DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : 20 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. NC-009468 IS ASSOCIATED WITH THIS LOT. THERE IS NO CORRELATION WITH THE FAILURE MODE. 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

    (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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> PC-(B)(4).

    Additional Manufacturer Narrative · 1

    COMPLETE PRODUCT DETAIL HAS NOT BEEN RECEIVED AT THIS TIME. IF FURTHER INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. 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

    PFS AND MEDICAL RECORD RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGE, PFS ALLEGES DECREASED TOLERANCE FOR ACTIVITY. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, PATIENT WAS REVISED TO ADDRESS FAILED RIGHT TOTAL HIP ARTHROPLASTY SECONDARY TO METAL ON METAL WEAR AND ELEVATED METAL ION LEVELS. OPERATIVE NOTES REPORTED OF MINOR CLEAR FLUID, REACTIVE DEBRIS AND TRUNNIONOSIS. IT WAS INDICATED THAT THERE WAS NO EXTENSIVE METALOSIS BEHIND THE METAL SHELL. CLINIC VISITS COMPLAINT OF PAIN. SOFT TISSUE HIP BIOPSY REVEALED SOFT TISSUE NECROSIS WITH PIGMENT- STAINED MACROPHAGES (CONSISTENT WITH METALLOSIS).

    Description of Event or Problem · 1

    LITIGATION RECORD RECEIVED. LITIGATION ALLEGES PAIN AND VERY ELEVATED SERUM COBALT LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757929 SROM STM STD 36+12L 13X18 HIP FEMORAL STEM JDI DEPUY IRELAND 9616671 3180077

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention