BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 8

    MDR report key: 6198650 · Received December 22, 2016

    Report

    Report Number
    1818910-2016-33870
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    November 15, 2016
    Report Date
    December 8, 2016
    Manufacturer
    DEPUY FRANCE SAS¿ 3003895575
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    A COMPLAINT DATABASE SEARCH DID NOT IDENTIFY ANY ANOMALIES. WITHOUT FURTHER INFORMATION OR RETURN OF THE PRODUCT THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; ENTERED INTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. IF FURTHER INFORMATION IS RECEIVED THE COMPLAINT SHALL BE REOPENED AND INVESTIGATED FURTHER. POST MARKET SURVEILLANCE IS PER (B)(4). 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.

    Additional Manufacturer Narrative · 1

    DEPUY16-56. THE PATIENT ON (B)(6)2010 RECEIVED A PINNACLE IMPLANT 48MM WITH METAL INSERT. RECENTLY HIGH IONS LEVELS OF CR AND CO WERE DETECTED IN BLOOD (CR=10.6 MICROGR/L / CO=7.00 MICROGR/L ) UPDATE (B)(6)2016 - SUBSEQUENTLY THE PATIENT ACCUSED PAIN AND HIGH IONS LEVELS WERE DETECTED. THE SOURCE OF IONS IS NOT DETERMINED AND SO BOTH DEPUY IMPLANTS (LEFT AND RIGHT) COULD HAVE CONTRIBUTED TO THE METALLOSIS. UPDATE 8-DEC-2016: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE LAB RESULTS CONFIRMED THE ELEVATED METAL ION LEVELS. PART/LOT PROVIDED. THE STEM, HEAD, AND LINER WERE ALL BE REPORTED AT THIS TIME. THIS COMPLAINT WAS UPDATED ON: 22-DEC-2016 UPDATE NOV 30, 2017: ADDITIONAL INFORMATION RECEIVED. THERE IS NO NEW INFORMATION ADDED THAT CHANGES THE MDR DECISION. ADDED ACETABULAR CUP PRODUCT INFORMATION. THIS COMPLAINT WAS UPDATED ON: DECEMBER 08, 2017 THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. 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. 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

    (B)(4). THE PATIENT ON (B)(6) 2010 RECEIVED A PINNACLE IMPLANT 48MM WITH METAL INSERT. RECENTLY HIGH IONS LEVELS OF CR AND CO WERE DETECTED IN BLOOD (CR=10.6 MICROGR/L / CO=7.00 MICROGR/L). UPDATE 30 NOV 2016 - SUBSEQUENTLY THE PATIENT ACCUSED PAIN AND HIGH IONS LEVELS WERE DETECTED. THE SOURCE OF IONS IS NOT DETERMINED AND SO BOTH DEPUY IMPLANTS (LEFT AND RIGHT) COULD HAVE CONTRIBUTED TO THE METALLOSIS. UPDATE 8-DEC-2016: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE LAB RESULTS CONFIRMED THE ELEVATED METAL ION LEVELS. PART/LOT PROVIDED. THE STEM, HEAD, AND LINER WERE ALL BE REPORTED AT THIS TIME. THIS COMPLAINT WAS UPDATED ON: 22-DEC-2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850511 CORAIL2 STD SIZE 8 HIP FEMORAL STEM/SLEEVE KWA DEPUY FRANCE SAS¿ 3003895575 5022735

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R