BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ¿REVERSE BASEPLATE 15MM¿

    MDR report key: 6269978 · Received January 23, 2017

    Report

    Report Number
    1651501-2017-00002
    Event Type
    Injury
    Date Received
    January 23, 2017
    Report Date
    January 5, 2017
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    K130050
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON FEBRUARY 8, 2017. THE INVESTIGATION INCLUDED: METHODS: REVIEW OF DEVICE HISTORY RECORDS, REVIEW OF COMPLAINTS HISTORY. RESULTS: THE DEVICE WAS NOT RETURNED AND A REVISION SURGERY IS SCHEDULED FOR (B)(6) 2017. THE OUTCOME OF THE SURGERY IS UNKNOWN. IT IS UNKNOWN IF THERE WAS INJURY OR ANY OTHER TRAUMATIC EVENTS LEADING TO THE DISCOVERY OF THE ISSUE. DHR REVIEW; THE COMPLAINT REPORT DOES NOT INCLUDE THE DEVICE LOT NUMBER; THEREFORE, A DHR REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED COMPLAINTS HISTORY; A REVIEW OF COMPLAINT RECORDS SHOWED THAT SINCE PRODUCT INCEPTION IN 2013, 2 COMPLAINTS HAVE BEEN RECEIVED FOR GLS-0960-030-15 GLENOSPHERE/REVERSE BASEPLATE: DISASSOCIATION, DISENGAGEMENT, OR LOOSENING. HOWEVER, DURING THIS PERIOD OF TIME, THERE HAVE BEEN 16 COMPLAINTS FOR THE GLENOSPHERE- DISASSOCIATION, DISENGAGEMENT OR LOOSENING UNDER ITS MATING PART, GLS-0960-02E. CURRENTLY, THERE HAVE BEEN (B)(4) RSS SURGERIES PERFORMED. THIS REPRESENTS (B)(4) OVERALL FAILURE RATE. AN ADVERSE TREND HAS BEEN IDENTIFIED CONCLUSION: THE ROOT CAUSE COULD NOT BE DETERMINED. PREVIOUS INSTANCES MAY HAVE BEEN CAUSED BY IMPROPER SEATING AND POOR ENGAGEMENT TO THE BASEPLATE.

    Description of Event or Problem · 1

    REPORT 2 OF 2: OTHER MFG REPORT NUMBER - 1651501-2017-00001. IT WAS REPORTED THAT AFTER THE PATIENT HAD A REVERSE SHOULDER PROCEDURE THE SURGEON FOUND A DISSOCIATION OF THE GLENOSPHERE COMPONENT FROM THE GLENOID COMPONENT. PATIENT IS SCHEDULED FOR A REVISION SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53243 ¿REVERSE BASEPLATE 15MM¿ TITAN SHOULDER SYSTEM KWS ASCENSION ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4)- GLENOSPH ECC 2MMTITAN SHOULDERSYSTEM