BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL AMT COLLAR SIZE 11

    MDR report key: 4172807 · Received October 15, 2014

    Report

    Report Number
    1818910-2014-29441
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    July 14, 2011
    Report Date
    November 24, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS OF INFECTION AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE PATIENT WAS PRIMARILY IMPLANTED IN (B)(6) 2007 AND REVISED FOR INFECTION AND ASSOCIATED PAIN IN (B)(6) 2012. IT IS NOT LIKELY OR REASONABLE TO CONCLUDE THE DEPUY DEVICES CONTRIBUTED TO THE PATIENT'S REPORTED INFECTION MORE THAN FOUR YEARS POST PRIMARY IMPLANTATION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGAL SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - LITIGATION PAPERS ALLEGE: PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HER RIGHT SIDE ON OR ABOUT (B)(6) 2007. PATIENT EXPERIENCED PAIN AND ELEVATED LEVELS OF COBALT AND CHROMIUM. SHE HAS NOT YET SCHEDULED AN EXPLANTATION OF THE ASR HIP IMPLANT. DOI: (B)(6) 2007 - DOR: UNK (RIGHT SIDE). PATIENT IS A RESIDENT OF (B)(6). UPDATE: 4/2/2012 - THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED DUE TO PAIN AND INFECTION. DOR: (B)(6) 2012. UPDATE REC'D 4/3/2013- PPD AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE REVISION OPERATIVE NOTE INDICATED THE CUP WAS LOOSE AND THE HIP WAS INFECTED. ALL IMPLANTS WERE REMOVED AND PROSTALAC WAS IMPLANTED. THE MDR DECISION FOR THE STEM AND TAPER SLEEVE IS BEING REEVALUATED AS ALL INFECTION IS REPORTED PER DEPUY'S LEGAL PROCEDURE. A REIMPLANTATION DATE IS UNKNOWN AT THIS TIME. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 10/6/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652974 CORAIL AMT COLLAR SIZE 11 HIP FEMORAL STEM/SLEEVE KWA DEPUY ORTHOPAEDICS, INC. 2394008

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention