BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 2840996 · Received November 20, 2012

    Report

    Report Number
    1818910-2012-25408
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    March 1, 2011
    Report Date
    October 25, 2012
    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
    CA, 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT EXPERIENCED PAIN IN THE GROIN MONTHS AFTER THAT SURGERY. AT THE TIME OR THE REVISION SURGERY ON (B)(6) 2011, THE PATIENT SHOWED NO SIGNS OF INFECTION AND THE ACETABULAR COMPONENT WAS IN EXCELLENT POSITION. WHEN THE ACETABULAR COMPONENT WAS LOOSENED THERE WAS A SMALL AREA OF APPROXIMATELY ONE QUARTER INCH BY ONE HALF INCH OF DENSE BONE ATTACHED TO THE SUPERIOR RIM. ANOTHER BAND OF APPROXIMATELY ONE QUARTER INCH BY ONE HALF INCH WAS NOTED NEAR THE DOME. THE CUP WAS OTHERWISE WITHOUT EVIDENCE OF BONE ATTACHMENT. THERE WAS NO BONE INGROWTH INTO THE POROUS COATING WHICH WAS EXTREMELY UNUSUAL FOR A POROUS-COATED IMPLANT THAT HAD BEEN IN THE PATIENT'S LEFT HIP FOR APPROXIMATELY FIVE YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 50 ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention