BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPLANT SIZE 43

    MDR report key: 2211807 · Received August 10, 2011

    Report

    Report Number
    1818910-2011-15417
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    August 18, 2014
    Report Date
    August 18, 2014
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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. REF. (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

    PLAINTIFF'S PRELIMINARY DISCLOSURE (PPD) FORM, OPERATIVE REPORT AND IMPLANT LOG WITH IMPLANT STICKERS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION AND DATE OF IMPLANT. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY STILL 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 THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC INJURIES: PAST MEDICAL EXPENSES, FUTURE MEDICAL EXPENSES, PAST LOST WAGES, FUTURE LOST WAGES, PAST AND FUTURE CONSCIOUS PAIN AND SUFFERING, PHYSICAL INJURY, BODILY IMPAIRMENT, MENTAL ANGUISH, EMOTIONAL DISTRESS AND LOSS OF ENJOYMENT OF LIFE. IT IS ALSO ALLEGED THE PATIENT COULD NOT HAVE KNOWN THAT SHE WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT UNTIL AFTER THE DATE SHE HAD HER BLOOD DRAWN AND SHE WAS ADVISED OF THE RESULTS OF SAID BLOOD-WORK. PATIENT HAS NOT YET SCHEDULED AN EXPLANTATION OF THE ASR HIP IMPLANT.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - LITIGATION PAPERS ALLEGE PATIENT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC INJURIES: PAST MEDICAL EXPENSES, FUTURE MEDICAL EXPENSES, PAST LOST WAGES, FUTURE LOST WAGES, PAST AND FUTURE CONSCIOUS PAIN AND SUFFERING, PHYSICAL INJURY, BODILY IMPAIRMENT, MENTAL ANGUISH, EMOTIONAL DISTRESS AND LOSS OF ENJOYMENT OF LIFE. IT IS ALSO ALLEGED THE PATIENT COULD NOT HAVE KNOWN THAT SHE WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT UNTIL AFTER THE DATE SHE HAD HER BLOOD DRAWN AND SHE WAS ADVISED OF THE RESULTS OF SAID BLOOD-WORK. PATIENT HAS NOT YET SCHEDULED AN EXPLANTATION OF THE ASR HIP IMPLANT. DOI: (B)(6) 2008 - DOR: NONE REPORTED (LEFT SIDE). PATIENT IS A RESIDENT OF (B)(6). UPDATE 07/11/2011 PLAINTIFF'S PRELIMINARY DISCLOSURE (PPD) FORM, OPERATIVE REPORT AND IMPLANT LOG WITH IMPLANT STICKERS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION AND DATE OF IMPLANT. PRODUCTS UPDATED, DOI CORRECTED AND PPD ATTACHED TO FILE. FOLLOW-UP EMDRS FILED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DOI: (B)(6) 2008 - DOR: NONE REPORTED. UPDATE DER RCVD - ADDED DOR, SURGEON, HOSPITAL AND SALES REP INFORMATION, PAIN (AS A REASON FOR REVISION) AND SLEEVE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPLANT SIZE 43 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL, LTD. NA 2539918

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention