BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 58

    MDR report key: 2864231 · Received December 10, 2012

    Report

    Report Number
    1818910-2012-25482
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    January 5, 2011
    Report Date
    December 7, 2012
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. NOT RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED INJURIES AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANTS WHICH HAVE NOW INCLUDED BUT ARE NOT LIMITED TO BILATERAL HIP PAIN, FAILED LEFT TOTAL HIP, POPPING OF THE HIP JOINTS, LOOSENING OF THE COMPONENTS, ELEVATED METAL LEVELS IN THE BLOOD, METAL POISONING, NEED FOR EXPLANT SURGERY, PAIN AND SUFFERING, LOSS OF ENJOYMENT OF LIFE, AND NEGATIVE IMPACT ON ACTIVITIES OF DAILY LIVING.

    Description of Event or Problem · 1

    UPDATE (B)(6) 2012 - PATIENT FACT SHEET WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 58 ACETABULAR CUP HIP IMPLANT KWA 1981368

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention