BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 NON COL HO SIZE 12

    MDR report key: 7112352 · Received December 13, 2017

    Report

    Report Number
    1818910-2017-51464
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    August 1, 2016
    Report Date
    November 17, 2017
    Manufacturer
    DEPUY IRELAND 961610 
    Product Code
    KWL
    UDI-DI
    10603295258032
    PMA / PMN Number
    K123991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # : (B)(4). 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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

    IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PFS ALLEGES WEAKNESS. AFTER THE REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS AND CORROSION. REVISION NOTES REPORTED MUSCLE DEFICIENCY. THE CUP AND STEM WERE NOT REVISED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES AMBULATION DIFFICULTIES, SEVERE PAIN AND DISCOMFORT. DOI: (B)(6) 2007; DOR: (B)(6) 2016; RIGHT HIP; PINNACLE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894803 CORAIL2 NON COL HO SIZE 12 STEM KWL DEPUY IRELAND 961610  2378624 10603295258032

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention