BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 43

    MDR report key: 2112761 · Received May 19, 2011

    Report

    Report Number
    1818910-2011-08333
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    January 3, 2007
    Report Date
    April 3, 2013
    Manufacturer
    DEPUY INTERNATIONAL, 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

    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

    DEPUY STILL 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 PRODUCT HAS NOT BEEN REVISED AS ORIGINALLY REPORTED. THIS PRODUCT IS STILL IMPLANTED AND HAS NOT BEEN REMOVED. THIS REPORT IS CONSIDERED CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PT HAS HAD AN ASR REVISION. SPECIFIC DETAILS REGARDING THE REPORT ARE UNK.

    Description of Event or Problem · 1

    ASR XL - LEFT; REASON(S) FOR REVISION: FEMORAL NECK FRACTURE ON RESURFACING (BEYOND 3 MONTHS OF POST OP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEM IMP SIZE 43 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 1209888

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention