BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAIL AMT SZ10 135 LOW N COL

    MDR report key: 8807015 · Received July 19, 2019

    Report

    Report Number
    1818910-2019-98749
    Event Type
    Malfunction
    Date Received
    July 19, 2019
    Date of Event
    June 27, 2019
    Report Date
    June 27, 2019
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    LZO
    UDI-DI
    10603295452546
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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 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: FOLLOWING REVIEW OF THE INFORMATION RECEIVED, IT WAS CONCLUDED THAT IT WAS NOT POSSIBLE TO DETERMINE IF A POTENTIAL PRODUCT ISSUE WAS PRESENT. THE COMPLAINT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE RECEIVED, THEN THE COMPLAINT SHALL BE REVIEWED AND FURTHER INVESTIGATION COMPLETED AS REQUIRED. DEVICE HISTORY LOT: 8890789. DEVICE HISTORY REVIEW: PRODUCT CODE L981310, WORK ORDER (B)(4) WAS MANUFACTURED ON 12-OCTOBER-2018. (B)(4) PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). 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 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.

    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

    SURGEON PUT CORAIL INTO THE FEMUR OF PATIENT AFTER THAT HE CHECKED STABILITY. HE HEARD THE SOUND FROM SOMETHING LIKE A CRACK/FRACTURE DURING TESTING. HE CHECKED THE PATIENT AND HE SAW SOME CRACK OR CORAIL STEM. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 30MINS. ACTION TAKEN WHEN EVENT OCCURRED? THE SURGEONS TRIED TO REMOVED THE CORAIL BUT IT CAN'T REMOVE. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600320 CORAIL AMT SZ10 135 LOW N COL CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM LZO DEPUY FRANCE SAS 3003895575 8890789 10603295452546

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR