BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUP 50

    MDR report key: 2871567 · Received December 13, 2012

    Report

    Report Number
    1818910-2012-22355
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 28, 2012
    Report Date
    April 5, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    **UPDATE** (B)(4) 2013 - PPD RECEIVED. PART/LOT HAS BEEN UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY CONSIDERS THIS COMPLAINT CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    LEGAL CLAIM RECEIVED. UPDATE: (B)(6) 2012-SALES REP REPORTED REVISION SURGERY DUE TO PAIN AND ELEVATED METAL IONS. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION

    Description of Event or Problem · 1

    LEGAL CLAIM RECEIVED. UPDATE SALES REP REPORTED REVISION SURGERY DUE TO PAIN AND ELEVATED METAL IONS. UPDATE LITIGATION ALLEGED THE PATIENT SUFFERED PAIN, EXPOSURE TO METAL IONS, RISK OF IMPLANT LOOSENING AND, ULTIMATELY, PREMATURE REPLACEMENT OF THE ASR HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUP 50 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2246155

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention