BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUP GYROS SANS PATTE D46

    MDR report key: 10335545 · Received July 28, 2020

    Report

    Report Number
    1818910-2020-17062
    Event Type
    Malfunction
    Date Received
    July 28, 2020
    Date of Event
    June 25, 2020
    Report Date
    July 17, 2020
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : FOLLOWING REVIEW OF THE INFORMATION RECEIVED, IT WAS CONCLUDED THAT IT WAS UNLIKELY THAT 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PATIENT CODE: NO CODE AVAILABLE (3191) WAS USED TO CAPTURE PROLONGED SURGERY AND NO SIGNS, SYMPTOMS OR PATIENT INVOLVEMENT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATED THAT THERE WAS A 5-MINUTE DELAY.

    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

    DURING THE UNPACKING OF THE DEVICE, THE USER NOTICED THE SEAL WAS DAMAGED. USE OF ANOTHER DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCE. DELAY OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798559 CUP GYROS SANS PATTE D46 GYROS ACETABULAR HIP IMPLANTS : HIP METAL ACETABULAR CUPS LXH DEPUY FRANCE SAS - 3003895575 5262072

    Patients

    Seq Age Sex Outcome Treatment
    1