BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAIL AMT SZ11 135 HIGH COL

    MDR report key: 8143791 · Received December 7, 2018

    Report

    Report Number
    1818910-2018-77573
    Event Type
    Malfunction
    Date Received
    December 7, 2018
    Date of Event
    October 22, 2018
    Report Date
    November 13, 2018
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    LZO
    UDI-DI
    10603295455301
    PMA / PMN Number
    K173960
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    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). A REVIEW OF MANUFACTURING RECORDS AND COMPLAINT DATABASES DID NOT IDENTIFY ANY ANOMALIES.NO DEVICE WAS RETURNED HENCE FURTHER EVALUATION COULD NOT BE CONDUCTED. ROOT CAUSE UNDETERMINED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT = PRODUCT CODE L971111, WORK ORDER (B)(4) WAS MANUFACTURED ON 02-AUG-2018. 10 PARTS WERE MANUFACTURED PER 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 · 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

    DISCREPANCY BETWEEN THE SIZE OF THE TRIALS AND REVISED DUE TO SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983065 CORAIL AMT SZ11 135 HIGH COL CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM LZO DEPUY FRANCE SAS 3003895575 8848592 10603295455301

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention