BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 NON COL HO SIZE 10

    MDR report key: 5103762 · Received September 25, 2015

    Report

    Report Number
    1818910-2015-31402
    Event Type
    Injury
    Date Received
    September 25, 2015
    Date of Event
    September 27, 2012
    Report Date
    September 24, 2015
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    KWA
    PMA / PMN Number
    PK042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS STILL UNDER INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: UNAVAILABLE. THIS COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.(B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT SUFFERS FROM TOXIC COBALT CHROMIUM METAL IONS, PAIN, DISCOMFORT, AND INFLAMMATION.

    Description of Event or Problem · 1

    UPDATE 1/19/16-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT SUFFERED A GREATER TROCHANTERIC FRACTURE ON (B)(6) 2010 THAT WAS CABLED. THE REVISION OPERATIVE NOTE INDICATED METALLOSIS, LOOSE STEM DUE TO FRACTURE, PAIN, METAL DEBRIS, AND ELEVATED METAL IONS (CONFIRMED BY LABS). THE STEM WASN'T REVISED. PART/LOT UPDATED. THE COMPLAINT WAS UPDATED ON:2/3/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636911 CORAIL2 NON COL HO SIZE 10 HIP FEMORAL STEM/SLEEVE KWA DEPUY FRANCE SAS - 3003895575 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention