BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNISYN HIP SYSTEM

    MDR report key: 4016968 · Received July 31, 2014

    Report

    Report Number
    2952369-2014-00004
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 31, 2014
    Manufacturer
    CONSENSUS ORTHOPEDICS INC
    Product Code
    JDI
    PMA / PMN Number
    K003649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DHR'S FOR THE (B)(4) UNISYN COMPONENTS WERE PULLED AND NO ANOMALIES OR ISSUES WERE IDENTIFIED. COMPLAINT AND ADVERSE EVENT RECORDS WERE ALSO REVIEWED AND NO TRENDS WERE IDENTIFIED. AN ENGINEERING DESIGN ANALYSIS OF THE UNISYN INCORPORATION THE NON-COI COMPONENTS SHOWED THAT THEY ESTABLISHED ADDITIONAL STRESSES ON THE UNISYN MODULAR STEM. PART/CATALOG. NUMBER PRODUCT DESCRIPTION LOT NUMBER: 3449-03000-0 LOCK, NUT, TI 30MM 720022; 3441-13046-A NECK, STANDARD, 30MM X 46MM 472736; 3461-53034-A PROXIMAL BODY, 30MM X 34MM, HA/PLASMA 471080AB; 3422-11716-0 STEM, FLUTED, STRAIGHT, 17 MM X 160MM 473152. TBD DEPUY FEMORAL HEAD 40MM, +12 OFFSET TBD. TBD DEPUY ACETABULAR INSERT TBD. TBD DEPUY ACETABULAR SHELL TBD. UNISYN HIP STEM WAS USED OFF-LABEL BY THE SURGEON (B)(6), I.E. USED WITH OVERSIZED METAL HEAD AND A METAL/METAL ACETABULAR CUP SYSTEM BOTH FROM A DIFFERENT MANUFACTURER (B)(4). REVISION SURGERY WAS PERFORMED AND THE ORIGINAL UNISYN STEM REMOVED AND REPLACED WITH A STEM FROM A DIFFERENT MANUFACTURER. THE ACETABULAR SHELL WAS LEFT IN PLACE, BUT THE METAL LINER WAS REPLACED WITH A POLY ONE.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT HIS UNISYN FRACTURED AT THE NECK WHEN HE WAS WALKING. HE FELL TO THE GROUND AND WENT IN AN AMBULANCE. TWO WEEKS BEFORE THE INCIDENT HE HEARD A CRUNCH OR CRACK, BUT HE DID NOT FEEL ANYTHING. HIS INITIAL IMPLANTATION SURGERY WAS ON (B)(6) 2009, WITH DR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448560 UNISYN HIP SYSTEM TOTAL HIP SYSTEM JDI CONSENSUS ORTHOPEDICS INC 472736

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR