BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 58

    MDR report key: 2142836 · Received June 23, 2011

    Report

    Report Number
    1818910-2011-11218
    Event Type
    Injury
    Date Received
    June 23, 2011
    Report Date
    May 24, 2011
    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
    AL, 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 THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE ON OR ABOUT (B)(6) 2009, PT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC INJURIES AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT: HIP PAIN, LOSS OF ENJOYMENT OF LIFE, METALLOSIS EXPOSURE AND OTHER INJURIES PRESENTLY UNDIAGNOSED. PT HAD THE LEFT ASR HIP IMPLANT EXPLANTED ON (B)(6) 2011. PT WILL BE HAVING THE RIGHT ASR HIP IMPLANT EXPLANTED DURING THE SUMMER OF 2011.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE ON OR ABOUT (B)(6) 2009, PATIENT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC INJURIES AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT: HIP PAIN, LOSS OF ENJOYMENT OF LIFE, METALLOSIS EXPOSURE AND OTHER INJURIES PRESENTLY UNDIAGNOSED. PATIENT HAD THE LEFT ASR HIP IMPLANT EXPLANTED ON (B)(6), 2011. PATIENT WILL BE HAVING THE RIGHT ASR HIP IMPLANT EXPLANTED DURING THE (B)(6) OF 2011. UPDATE: (B)(4) 2012 - THE SALES REP HAS REPORTED THE REVISION FOR THE RIGHT SIDE. PATIENT WAS REVISED DUE TO PAIN AND POSSIBLY METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 58 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2242838

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention