BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 NON COL HO SIZE 10

    MDR report key: 9008448 · Received September 12, 2019

    Report

    Report Number
    1818910-2019-104141
    Event Type
    Injury
    Date Received
    September 12, 2019
    Date of Event
    August 20, 2019
    Report Date
    August 21, 2019
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    KWA
    UDI-DI
    10603295258018
    PMA / PMN Number
    K042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A DUPLICATE REPORT OF 1818910-2019-102853. 1818910-2019-104141 IS BEING RETRACTED AS IT IS A REPORT DUPLICATION. 1818910-2019-102853 WILL BE KEPT FOR INVESTIGATION.

    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

    THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019 VIA THA. IT WAS REPORTED THAT THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) , 2019 BY EXPLANTING THE STEM (P/N: L20310), THE HEAD (P/N: 136532330) DUE TO POSTOPERATIVE INFECTION. THE SURGERY WAS COMPLETED WITHIN A 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809425 CORAIL2 NON COL HO SIZE 10 HIP FEMORAL STEM KWA DEPUY FRANCE SAS - 3003895575 5230497 10603295258018

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention