BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL AMT COLLAR SIZE 8

    MDR report key: 9261010 · Received October 31, 2019

    Report

    Report Number
    1818910-2019-113377
    Event Type
    Injury
    Date Received
    October 31, 2019
    Date of Event
    October 7, 2019
    Report Date
    October 7, 2019
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    JDI
    UDI-DI
    10603295168645
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY AS NOT BSYNTHES 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. 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. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. FOLLOWING REVIEW BY BIOENGINEERING, NOTIFICATION WAS RECEIVED THAT: "DUE TO THE LACK OF INFORMATION AVAILABLE IT IS NOT POSSIBLE TO ESTABLISH A ROOT CAUSE, EITHER FOR THE CALCAR FRACTURE OR THE COLLARED STEM FAILING TO SEAT. SPECIFICALLY "THE COMPLAINT QUESTIONS WHY THERE IS NO SIZE 7 STEM AVAILABLE AT THIS TIME?... CAN THIS BE INVESTIGATED AND ANY FUTURE PLANS TO MANUFACTURE A SIZE 7 STEM BE RELAYED BACK". THE DEPUY INTERNATIONAL RESEARCH & DEVELOPMENT HIP NPD TEAM WERE CONTACTED REGARDING THE ABOVE QUERY. THE FOLLOWING RESPONSE ADDRESSES THE COMPLAINT QUESTIONS: "DEPUY SYNTHES ARE DEVELOPING SIZE 7 STEMS (AND BROACH) FOR THE CORAIL SYSTEM, THEY ARE NOT CURRENTLY LAUNCHED. THIS DEVICE IS ONLY CURRENTLY PLANNED TO BE LAUNCHED TO THE JAPANESE MARKET, AND THEREFORE IS NOT PLANNED TO BE MADE AVAILABLE IN THE IRELAND MARKET. ALL COMPLAINTS RECEIVED BY DEPUY SYNTHES ARE LOGGED IN A COMPLAINT SYSTEM, AND COMPLAINTS ARE TRENDED FOR COMPLAINT TRIGGERS. WE HAVE A DEDICATED TEAM WHO WILL RESPOND APPROPRIATELY IF A TREND AROUND DEFICIENCIES IN THE SIZE RANGE OF CORAIL IS IDENTIFIED". 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. CORRECTIVE ACTION WAS NOT INDICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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

    WAS THE SURGERY PROLONGED DUE TO THE EVENT? IF YES, CONFIRM HOW MANY MINUTES DELAY: 1 HOUR. WHILE BROACHING A FEMUR WITH BROACH SIZE 8, A FRACTURE APPEARED IN THE CALCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053229 CORAIL AMT COLLAR SIZE 8 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM JDI DEPUY FRANCE SAS - 3003895575 10603295168645

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention