BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 60

    MDR report key: 3132352 · Received May 29, 2013

    Report

    Report Number
    1818910-2013-05502
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    November 21, 2012
    Report Date
    January 14, 2014
    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
    MA, 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. REF. (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

    THE 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2014- PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE PATIENT SUFFERED WEAKNESS, SORENESS, A GRINDING SENSATION WITHIN THE JOINT, ANTALGIC GAIN, PAIN, TENDERNESS, CYSTIC LESIONS AND DANGEROUSLY HIGH BLOOD LEVELS OF CHROMIUM AND COBALT SINCE BEING IMPLANTED WITH THE ASR HIP. CHROMIUM LEVELS WERE ALLEGEDLY MEASURED AT 2.7 ON (B)(6) 2010, 1.4 ON (B)(6) 2011, AND 2.3 ON (B)(6) 2012; WHILE COBALT LEVELS WERE MEASURED AT 3.0 ON (B)(6) 2010, 2.8 ON (B)(6) 2011, AND 4.6 ON (B)(6) 2012. AN MRI OF THE IMPLANT SITE REPORTEDLY REVEALED MODERATE ADVERSE TISSUE REACTION AND ANTERIOR COLUMN AND FOCAL FEMORAL OSTEOLYSIS WITH PROMINENT BONE RESORPTION PROXIMAL FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236995 ASR ACETABULAR CUPS 60 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2416134

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention