BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1818910-2019-94582

    MDR report key: 8645700 · Received May 28, 2019

    Report

    Report Number
    1818910-2019-94582
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    February 25, 2016
    Report Date
    November 11, 2016
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: 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. THE INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS WAS CONDUCTED UNDER MDD CAPA-(B)(4). ONGOING POST MARKET SURVEILLANCE IS CONDUCTED PER OUR PROCEDURES FOR THIS PRODUCT. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT PRODUCT CODE IS SOLD INTERNATIONALLY. IT IS SOLD IN THE US UNDER A DIFFERENT PRODUCT CODE.

    Description of Event or Problem · 1

    REVISION DUE TO ALVAL / SOFT TISSUES REACTION.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention