BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 62

    MDR report key: 2213225 · Received August 12, 2011

    Report

    Report Number
    1818910-2011-15078
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    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

    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 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 THE INVESTIGATION CLOSED. 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 PAPERS ALLEGE PT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC INJURED: 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. PT HAS NOT YET SCHEDULED AN EXPLANTATION OF THE ASR HIP IMPLANT.

    Description of Event or Problem · 1

    NEW (B)(6) RECORD CREATED IN ORDER TO UPDATE (B)(6) (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. PATIENT HAS NOT YET SCHEDULED AN EXPLANTATION OF THE ASR HIP IMPLANT DOI: (B)(6) 2009 - DOR: NONE REPORTED (LEFT SIDE) PATIENT IS A RESIDENT OF (B)(6). UPDATE 9 JULY 2014 - DER RCVD - UPDATED DOR, PATIENT AGE, SURGEON / HOSPITAL, PRODUCT DETAILS RECEIVED. ADDED FLUID TO REASONS FOR REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 62 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL, LTD. NA 2762657

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention