BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 2111541 · Received May 13, 2011

    Report

    Report Number
    1818910-2011-08355
    Event Type
    Injury
    Date Received
    May 13, 2011
    Report Date
    April 30, 2012
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: LITIGATION PAPERS ALLEGE PATIENT HAS SUSTAINED AND WILL CONTINUE TO SUSTAIN CONTAMINATION OF AND DAMAGE TO TISSUES AND BLOOD, SUBSEQUENT SURGERY, PAIN, SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND ECONOMIC DAMAGES. DOI: (B)(6) 2006 - DOR: NO REVISION REPORTED AT THIS TIME. (UNKNOWN SIDE). PATIENT IS A RESIDENT OF (B)(6). UPDATE: (B)(4) 2011 - THE SALES REP REPORTED THE REVISION SURGERY. THE PATIENT WAS REVISED. THE REASON FOR REVISION WAS REPORTED AS: DUE TO THE RECALL. DOR: (B)(6) 2011. 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

    THIS 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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT HAS SUSTAINED AND WILL CONTINUE TO SUSTAIN CONTAMINATION OF AND DAMAGE TO TISSUES AND BLOOD, SUBSEQUENT SURGERY, PAIN, SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND ECONOMIC DAMAGES.

    Description of Event or Problem · 1

    (B)(4) 2012 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED SIDE AND 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
    1 ASR ACETABULAR CUPS 50 NONE KWA DEPUY INTERNATIONAL, LTD. NA 2229257

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention