BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI-LOCK BPS SZ 0 HI OFFSET

    MDR report key: 6849204 · Received September 7, 2017

    Report

    Report Number
    1818910-2017-24217
    Event Type
    Injury
    Date Received
    September 7, 2017
    Date of Event
    August 8, 2017
    Report Date
    August 8, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    UDI-DI
    10603295001027
    PMA / PMN Number
    K073570
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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.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.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.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

    COMPLAINT DESCRIPTION: DER STATES THAT THE O HI TRILOCK STEM SAT AT ABOUT 5MM PROUD AS COMPARED TO THE O HI BROACH. IT WAS ALSO REPORTED THAT THE SURGEON SPECULATED THE GRIPTION ON THE IMPLANT THAT MAY HAVE BEEN THICK.

    Description of Event or Problem · 1

    DER STATES THAT THE O HI TRILOCK STEM SAT AT ABOUT 5MM PROUD AS COMPARED TO THE O HI BROACH. IT WAS ALSO REPORTED THAT THE SURGEON SPECULATED THE GRIPTION ON THE IMPLANT THAT MAY HAVE BEEN THICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627924 TRI-LOCK BPS SZ 0 HI OFFSET HIP FEMORAL STEM/SLEEVE KWA DEPUY ORTHOPAEDICS INC US H12212 10603295001027

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR