BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY STEM

    MDR report key: 5207530 · Received November 6, 2015

    Report

    Report Number
    1818910-2015-34567
    Event Type
    Injury
    Date Received
    November 6, 2015
    Date of Event
    October 21, 2015
    Report Date
    October 21, 2015
    Manufacturer
    OCT 21, 2015
    Product Code
    JDG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    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. 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. NO UDI FOR ASR.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO PAIN AND ELEVATED IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738657 UNKNOWN DEPUY STEM HIP FEMORAL STEM/SLEEVE JDG OCT 21, 2015 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention