BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAIL AMT SZ10 135 HIGH COL

    MDR report key: 9314840 · Received November 13, 2019

    Report

    Report Number
    1818910-2019-115871
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    January 1, 2019
    Report Date
    October 17, 2019
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    JDI
    UDI-DI
    10603295455295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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.  INVESTIGATION SUMMARY : EXAMINATION OF THE PHOTOS, AS WELL AS THE RETURNED PACKAGED DEVICE CONFIRMS THE SMALL HOLE IN THE TYVEK LID MATERIAL. THIS DOES NOT HOWEVER AFFECT DEVICE STERILITY. 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 : NULL. DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : NULL.

    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: EXAMINATION OF THE PHOTOS, AS WELL AS THE RETURNED PACKAGED DEVICE CONFIRMS THE SMALL HOLE IN THE TYVEK LID MATERIAL. THIS DOES NOT HOWEVER AFFECT DEVICE STERILITY. 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: NULL. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. 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 #: (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

    IT WAS REPORTED THAT THE SURGEON ASKED FOR KHO COLLARED SIZE 10 STEM. UPON BOX BEING OPENED, A HOLE WAS NOTICED IN THE STERILE PACKAGING WHICH COMPROMISED THE STERILITY OF THE STEM. THEY GOT THE OTHER SIZE 10 KHO COLLARED IMPLANT AT THE FACILITY AND THAT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108374 CORAIL AMT SZ10 135 HIGH COL CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM JDI DEPUY FRANCE SAS - 3003895575 9016437 10603295455295

    Patients

    Seq Age Sex Outcome Treatment
    1