BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AML HIGH OFFSET LG STAT 16.5MM

    MDR report key: 7185589 · Received January 12, 2018

    Report

    Report Number
    1818910-2018-51061
    Event Type
    Malfunction
    Date Received
    January 12, 2018
    Date of Event
    December 18, 2017
    Report Date
    December 18, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 181891
    Product Code
    JDI
    UDI-DI
    10603295058465
    PMA / PMN Number
    K012364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    PRODUCT COMPLAINT # : (B)(4). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DER STATE THAT THE AML 16.5MM HIGH OFFSET STEM PACKAGING WAS CRACKED AND PRODUCT WAS NOT STERILE IN PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29991 AML HIGH OFFSET LG STAT 16.5MM HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS, INC. 181891 CD8BW1000 10603295058465

    Patients

    Seq Age Sex Outcome Treatment
    1