BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIS COLLARED HIGH SIZE 6

    MDR report key: 7129031 · Received December 19, 2017

    Report

    Report Number
    1818910-2017-52072
    Event Type
    Injury
    Date Received
    December 19, 2017
    Date of Event
    August 31, 2017
    Report Date
    November 22, 2017
    Manufacturer
    DEPUY IRELAND 961610 
    Product Code
    KWL
    UDI-DI
    10603295380580
    PMA / PMN Number
    K160907
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: 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.

    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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DUPLICATE REPORTING. IMPLANT AND EVENT HAVE PREVIOUSLY BEEN REPORTED.

    Description of Event or Problem · 1

    CLINICAL DER STATES THAT AE RECEIVED FOR DEEP INFECTION, RIGHT TOTAL HIP. EVENT DOES MEET THE DEFINITION OF SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. TREATMENT INCLUDES REVISION OF DEPUY HEAD AND LINER ON (B)(6) 2017. DOI: (B)(6) 2017; AE: (B)(6) 2017 REVISION: (B)(6) 2017 RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908678 ACTIS COLLARED HIGH SIZE 6 HIP FEMORAL STEM KWL DEPUY IRELAND 961610  H77821 10603295380580

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention