BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 2862377 · Received December 10, 2012

    Report

    Report Number
    1818910-2012-26953
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 19, 2012
    Report Date
    August 15, 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
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    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 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

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO PAIN. (LEFTT HIP).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 50 ACETABULAR CUP KWA DEPUY INTERNATIONAL 2440798

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention