BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 NON COL HO SIZE 12

    MDR report key: 3063599 · Received April 17, 2013

    Report

    Report Number
    1818910-2013-15498
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    November 23, 2012
    Report Date
    February 6, 2017
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODE 2821959. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 3005744 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE PART AND LOT CODE COMBINATION WAS NOT PROVIDED FOR THE UNKNOWN DEPUY DEVICE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    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. 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. 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

    LITIGATION ALLEGES PAIN, LOOSENING AND METALLOSIS.

    Description of Event or Problem · 1

    UPDATE 02/06/2017 ¿PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, THE REVISION SURGERY NOTES REPORTED THAT THE PATIENT HAD INCREASING PAIN AND THE SURGICAL FINDINGS INCLUDED METALLOSIS, GROSS LOOSENING OF THE PROXIMAL 3/4TH OF THE FEMORAL STEM WITH MINIMAL FIXATION AND MINIMAL SURROUNDING TISSUE NECROSIS. THE COMPLAINT WAS UPDATED ON: 02/14/2017

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165036 CORAIL2 NON COL HO SIZE 12 HIP FEMORAL STEM/SLEEVE KWA DEPUY FRANCE SAS 3003895575 5006242

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention