BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY FEMORAL HEAD

    MDR report key: 3121587 · Received May 21, 2013

    Report

    Report Number
    1818910-2013-06806
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    May 6, 2013
    Report Date
    December 19, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWY
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    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). 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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    UPDATE: (B)(6) 2013 - MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE PATIENT WAS REVISED DUE TO METALLOSIS, A BULGING CAPSULE WITH DEBRIS AND GREY METAL TINGED FLUID. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO ELEVATED COCR LEVELS AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224183 UNKNOWN DEPUY FEMORAL HEAD FEMORAL HEAD KWY DEPUY INTERNATIONAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention