BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 2111397 · Received May 13, 2011

    Report

    Report Number
    1818910-2011-08571
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    February 11, 2011
    Report Date
    April 15, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE STEM THAT WAS REPORTEDLY LOOSE DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. STERILIZATION CERTIFICATIONS HAVE BEEN REVIEWED FOR ALL DEVICE PRODUCT/LOT COMBINATIONS ASSOCIATED WITH THIS REPORT. THERE WERE NO DEVIATIONS OR ANOMALIES IDENTIFIED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS HIP PAIN, FEMORAL LOOSENING AND INFECTION. DOI: UPDATE: (B)(6) 2011 - LITIGATION PAPERS ALLEGE PT 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 50 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2537663

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention