BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 LAT COXA VARA SIZE 11

    MDR report key: 3121494 · Received May 21, 2013

    Report

    Report Number
    1818910-2013-06803
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    July 19, 2013
    Manufacturer
    DEPUY FRANCE
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE (B)(4) AND INTERNATIONAL COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE FEMORAL STEM PRODUCT AND LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. IT IS KNOWN THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4).DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING THE REVISION REPORT STATING PAIN AND STEM LOOSENING. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE..

    Description of Event or Problem · 1

    UPDATE - MEDICAL RECORDS RECEIVED (B)(4) 2013. REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: PAIN; EROSION; METAL STAINING; LOOSE STEM; METAL STAINED DEBRIS; GRANULOMATOUS AND METAL DEBRIS TISSUE. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION.

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE PATIENT SUFFERED PAIN, GRINDING, CLICKING AND POPPING OF HIS HIP JOINT, DIFFICULTY WALKING, INSTABILITY, PHYSICAL LIMITATIONS, PERMANENT DISABILITY AND DISFIGUREMENT, AND EXPOSURE TO EXCESSIVE LEVELS OF CHROMIUM AND COBALT AS A RESULT OF THE IMPLANTED ASR HIP. UPDATE: ((B)(6) 2013) - PATIENT FACT SHEET WAS RECEIVED. THE PART/LOT NUMBERS HAVE BEEN UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE: (B)(4) 2013 -SALES REP REPORTED REVISION SURGERY ON RIGHT HIP DUE TO PAIN AND STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224037 CORAIL2 LAT COXA VARA SIZE 11 HIP STEM KWA DEPUY FRANCE 2201908

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention