BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMIZED POSITIONING SYSTEM (OPS) INSIGHT

    MDR report key: 10261873 · Received July 12, 2020

    Report

    Report Number
    3012916784-2020-00062
    Event Type
    Malfunction
    Date Received
    July 12, 2020
    Date of Event
    July 3, 2020
    Report Date
    September 2, 2020
    Manufacturer
    OPTIMIZED ORTHO PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    K192656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    METHOD: NO COMPLAINT DEVICES WERE RETURNED TO OPTIMIZED ORTHO BY THE CUSTOMER. THUS, THE DEVICE HISTORY FILES WERE INVESTIGATED WHICH INCLUDED REVIEWING THE OPS INSIGHT, PRE-IMAGING OF THE PATIENT AND ALL MANUFACTURING STEPS OF IMPLANT POSITIONING AND REPORT GENERATION WERE REVIEWED. CONCLUSION: ACCORDING TO THE CONTACT PLOT GENERATED IN OPS INSIGHT THERE WAS NO INDICATION THAT THE PATIENT WOULD DISLOCATE AT THIS ORIENTATION. HOWEVER, THE SURGEON DID NOT UTILISE AN ACETABULAR GUIDE (NO ACETABULAR GUIDE WAS BOOKED, ONLY A FEMORAL GUIDE WAS REQUESTED) WHICH MAY HAVE CHANGED THE ACHIEVED ORIENTATION INTRA-OPERATIVELY. AS NO POST-OPERATIVE IMAGING WAS PROVIDED IT IS NOT POSSIBLE TO DETERMINE WHAT ORIENTATION WAS ACHIEVED AND HOW THAT CONTRIBUTED TO THE PATIENT REQUIRING A REVISION. THIS EVENT PREDOMINANTLY OCCURRED DUE TO CHANGES THE SURGEON MADE INTRA-OPERATIVELY. ALL THE RELEVANT PRODUCTION MANUFACTURING STEPS WERE COMPLETED CORRECTLY AS PER THE RELEVANT WORK INSTRUCTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A CORIN REPRESENTATIVE THAT THERE WAS A REVISION SURGERY DUE TO DISLOCATION AFTER THE PRIMARY SURGERY. THE PATIENT HAD THE GLOBAL CUP WITH PARAGON STEM IMPLANTED. DURING PRIMARY PROCEDURE , OPS TECHNOLOGY (OPS INSIGHT WITH FEMORAL GUIDE) WERE EMPLOYED AS ASSISTIVE TECHNOLOGY.

    Additional Manufacturer Narrative · 1

    WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CORIN REPRESENTATIVE THAT THERE WAS A REVISION SURGERY DUE TO DISLOCATION AFTER THE PRIMARY SURGERY. THE PATIENT HAD THE GLOBAL CUP WITH PARAGON STEM IMPLANTED. DURING PRIMARY PROCEDURE, OPS TECHNOLOGY (OPS INSIGHT WITH FEMORAL GUIDE) WERE EMPLOYED AS ASSISTIVE TECHNOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725864 OPTIMIZED POSITIONING SYSTEM (OPS) INSIGHT OPS INSIGHT LZO OPTIMIZED ORTHO PTY LTD SMA_AI_23219

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OPS FEMORAL GUIDE (1250-0100)| OPS FEMORAL GUIDE (1250-0100)