BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 LAT COXA VARA SIZE 16

    MDR report key: 8277425 · Received January 25, 2019

    Report

    Report Number
    1818910-2019-82282
    Event Type
    Injury
    Date Received
    January 25, 2019
    Date of Event
    January 7, 2019
    Report Date
    January 7, 2019
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    KWL
    UDI-DI
    10603295168935
    PMA / PMN Number
    K123991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. 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. 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 STEM APPEARS TO BE SLIGHTLY UNDERSIZED, IS LOOSE AT THE BONE TO IMPLANT INTERFACE AND HAS SUBSIDED. 16 KLA CORAIL COLLARED IN A TYPE C FEMUR. FEMUR ALSO EXHIBITS EXTREME FEMORAL BOW. PATIENT COMPLAINING OF PAIN AND LOSS OF LEG LENGTH DUE TO SUBSIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72746 CORAIL2 LAT COXA VARA SIZE 16 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM KWL DEPUY FRANCE SAS 3003895575 5284485 10603295168935

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention