BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 52

    MDR report key: 2250885 · Received September 16, 2011

    Report

    Report Number
    1818910-2011-18336
    Event Type
    Injury
    Date Received
    September 16, 2011
    Report Date
    August 18, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON (B)(6) 2008, PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP ON HER RIGHT SIDE. SHE HAS SUFFERED PAIN, SWELLING, INFLAMMATION, AND DAMAGE TO THE BONE AND TISSUE SURROUNDING THE IMPLANT. SHE MAY REQUIRE REVISION SURGERY. UPDATE: (B)(6) 2012 - THE SALES REP HAS REPORTED THE REVISION SURGERY. REPORT STATES THAT PATIENT HAD NO SYMPTOMS.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON (B)(6) 2008, PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP ON HER RIGHT SIDE. SHE HAS SUFFERED PAIN, SWELLING, INFLAMMATION, AND DAMAGE TO THE BONE AND TISSUE SURROUNDING THE IMPLANT. SHE MAY REQUIRE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 52 HIP KWA DEPUY INTERNATIONAL 2622694

    Patients

    Seq Age Sex Outcome Treatment
    1