BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ASR FEMORAL HEAD

    MDR report key: 3022580 · Received March 27, 2013

    Report

    Report Number
    1818910-2013-04339
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 20, 2013
    Report Date
    May 4, 2015
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KXA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO OSTEOLYSIS.

    Description of Event or Problem · 1

    UPDATE: (B)(6) 2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN, DISCOMFORT, AND INJURY . THE DOI WAS PROVIDED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION.

    Description of Event or Problem · 1

    UPDATE REC'D 5/4/2015 - MEDICAL RECORDS RECEIVED FROM LEGAL. UPON REVISION, A LARGE COLLECTION OF FLUID, DEBRIS MATERIAL, DARK BLACK CORROSION AT THE HEAD AND NECK JUNCTION, AND METALLOSIS WERE NOTED. THE STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT. THE STEM REMAINED IN SITU. THIS COMPLAINT WAS UPDATED ON 06/02/15.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125860 UNK ASR FEMORAL HEAD FEMORAL HEAD KXA DEPUY INTERNATIONAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention