BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 3030439 · Received April 2, 2013

    Report

    Report Number
    1818910-2013-03484
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    November 22, 2010
    Report Date
    August 16, 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
    TX, 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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD DISCOMFORT, PAIN, FATIGUE, SWELLING AND DIFFICULTY WALKING AND STANDING AFTER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013-LEGAL CLAIM RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM EXCESSIVE LEVELS OF CHROMIUM AND COBALT. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE AFFECT OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD DISCOMFORT, PAIN, FATIGUE, SWELLING AND DIFFICULTY WALKING AND STANDING AFTER ASR HIP IMPLANT. **UPDATE** (B)(4) 2013 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135107 ASR ACETABULAR CUPS 50 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2458299

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention