BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL HA W/O COLLAR S14 160MM

    MDR report key: 8635750 · Received May 23, 2019

    Report

    Report Number
    1818910-2019-94381
    Event Type
    Injury
    Date Received
    May 23, 2019
    Date of Event
    May 6, 2019
    Report Date
    May 6, 2019
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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 UNLIKELY THAT A POTENTIAL PRODUCT ISSUE WAS PRESENT. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION, IT 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: 1120273. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: THE DHR ANALYSIS OF THE BATCH RETURNED SHOWS AN INITIAL CONFORMANCE OF THIS PRODUCT WITH REGARDS TO ITS SPECIFICATION. FOR THIS BATCH, THERE WAS NO DEVIATION OR NON-CONFORMANCE. 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

    .

    Additional Manufacturer Narrative · 1

    (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

    PATIENT HAD TRAUMA DUE TO FALLING.

    Description of Event or Problem · 1

    IMPLANT FRACTURE (CORAIL K14), THE PRIMARY SURGERY WAS 19 YEARS AGO ((B)(6) 2011).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431377 CORAIL HA W/O COLLAR S14 160MM OTHER PRODUCTS KWA DEPUY FRANCE SAS 3003895575 1120273

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention