BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMIZED POSITIONING SYSTEM

    MDR report key: 11234355 · Received January 26, 2021

    Report

    Report Number
    3012916784-2021-00080
    Event Type
    Injury
    Date Received
    January 26, 2021
    Date of Event
    December 14, 2020
    Report Date
    April 5, 2021
    Manufacturer
    OPTIMIZED ORTHO PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    K171847
    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 PLAN, DYNAMIC HIP ANALYSIS REPORT, PATIENT SPECIFIC VISUALISATION REPORT, PRE-IMAGING, AND ALL MANUFACTURING STEPS OF IMPLANT POSITIONING AND REPORT GENERATION WERE REVIEWED. CONCLUSION: THIS CASE WAS PROCESSED ACCURATE ACCORDING TO THE WORK INSTRUCTIONS AND WAS PROCESSED THROUGH TO THE NEXT STAGE. THE CUP WAS PLACED ACCORDING TO THE WORK INSTRUCTIONS AND ADEQUATE BONY FIXATION WAS ACHIEVED. THE CAUSE OF THIS FAILURE IS UNRELATED TO THE USE OF OPS TECHNOLOGY. THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SAME/SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. PLEASE NOTE: THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AND ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A CORIN REPRESENTATIVE THAT THE PATIENT WAS REVISED DUE TO PAIN FROM CUP LOOSENING. OPS PLAN WITH DHA WERE USED AS AN ASSISTIVE TECHNOLOGY IN THE PRIMARY SURGERY.

    Additional Manufacturer Narrative · 1

    WE ARE CURRENTLY IN THE PROCESS OF RETRIEVING FURTHER INFORMATION TO PERFORM INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION. THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SAME/SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CORIN REPRESENTATIVE THAT THE PATIENT WAS REVISED DUE TO PAIN FROM CUP LOOSENING. OPS PLAN WITH DHA WERE USED AS AN ASSISTIVE TECHNOLOGY IN THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129144 OPTIMIZED POSITIONING SYSTEM OPTIMIZED POSITIONING SYSTEM LZO OPTIMIZED ORTHO PTY LTD OPS PLAN WITH DHA GAZ_MS_11982

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention