BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 45

    MDR report key: 2122768 · Received June 3, 2011

    Report

    Report Number
    1818910-2011-10024
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    September 4, 2011
    Report Date
    October 19, 2012
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED: EVENT/PROBLEM DESCRIPTION. 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).

    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

    CORRECTED/UPDATED DATA: (DATE OF EVENT); (DATE OF REPORT); (DATE OF EXPLANT); (DATE RECEIVED BY MANUFACTURER). DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    REASON FOR REVISION: PAIN.

    Description of Event or Problem · 1

    THE PT IS SCHEDULED FOR AN ASR REVISION TO ADDRESS PAIN (B)(6), 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEM IMP SIZE 45 87KWA KWA DEPUY INTL., LTD. NA 2225962

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention