BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 16

    MDR report key: 8211888 · Received January 3, 2019

    Report

    Report Number
    1818910-2019-79681
    Event Type
    Injury
    Date Received
    January 3, 2019
    Date of Event
    June 8, 2011
    Report Date
    December 6, 2018
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    KWA
    UDI-DI
    10603295168829
    PMA / PMN Number
    K042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEVICE HISTORY LOT: 1862361. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED PREVIOUSLY ON (B)(4). 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.

    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. (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS A MALPOSITIONED METAL LINER AND LEG LENGTH DISCREPANCY. OSTEOLYSIS WAS ALSO REPORTED. LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, SWELLING, INFLAMMATION, INFECTION, AND DAMAGE TO SURROUNDING BONE AND TISSUE, DISLOCATION, AND LACK OF MOBILITY. PPF ALLEGED ELEVATED METAL IONS. DOI: (B)(6) 2007; DOR: (B)(6) 2011 (RIGHT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6084 CORAIL2 STD SIZE 16 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM KWA DEPUY FRANCE SAS - 3003895575 1862361 10603295168829

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention