BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR 300 SPIKED CUP SIZE 58

    MDR report key: 2232648 · Received August 18, 2011

    Report

    Report Number
    1818910-2011-15745
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 25, 2011
    Report Date
    November 13, 2013
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K073413
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE (B)(4) WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 2010, AND THE (B)(4) 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 ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    UPDATE: (B)(4) 2012: LITIGATION DOCUMENTS WERE RECEIVED. LITIGATION ALLEGES THAT THE PATIENT SUFFERED INJURY AND EXCESSIVE LEVELS CHROMIUM AND COBALT. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS HIP PAIN.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. COMPLAINT UPDATED (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR 300 SPIKED CUP SIZE 58 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2770748

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention