BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9942344 · Received April 9, 2020

    Report

    Report Number
    3012916784-2020-00058
    Event Type
    Injury
    Date Received
    April 9, 2020
    Date of Event
    March 3, 2020
    Report Date
    July 12, 2020
    Manufacturer
    OPTIMIZED ORTHO PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    K152893
    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, PRE-IMAGING, OPS FEMORAL GUIDES. ALL MANUFACTURING STEPS OF IMPLANT POSITIONING AND REPORT GENERATION WERE REVIEWED. CONCLUSION: ALL OPERATIONS WERE COMPLETED CORRECTLY ACCORDING TO THE WORK INSTRUCTIONS. NO DEFICIENCY WAS FOUND WITH ANY OF THE OPS RELATED PROCESSES OR FEMORAL GUIDE. IT WAS NOTICED THROUGH ANALYSING THE USAGE THAT THE SURGEON DID NOT USE THE PLANNED SIZE 6 STEM AND INSTEAD USED A SIZE 4 STEM. IT IS LIKELY THAT THIS MAY HAVE CAUSED THE ISSUE DESCRIBED IN THIS REPORT. THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS 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 THERE WAS A REVISION DUE TO LEG LENGTH DISCREPANCY AS A RESULT OF UNDERSIZED SUBSIDED STEM AND PAIN IN THE HIP AFTER THE PRIMARY SURGERY. THE PATIENT HAD THE TRINITY CUP SYSTEM IMPLANTED WITH METAFIX STEM. DURING PRIMARY PROCEDURE , OPS TECHNOLOGY (OPS PLAN WITH DHA & FEMORAL GUIDE) WERE EMPLOYED AS ASSISTIVE TECHNOLOGY.

    Additional Manufacturer Narrative · 1

    WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION AND COMPLETE THE ROOT CAUSE INVESTIGATION. THE FINAL REPORT WILL BE SENT UPON CLOSURE OF ROOT CAUSE INVESTIGATION. THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS 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 THERE WAS A REVISION DUE TO LEG LENGTH DISCREPANCY AS A RESULT OF UNDERSIZED SUBSIDED STEM AND PAIN IN THE HIP AFTER THE PRIMARY SURGERY. THE PATIENT HAD THE TRINITY CUP SYSTEM IMPLANTED WITH METAFIX STEM. DURING PRIMARY PROCEDURE , OPS TECHNOLOGY (OPS PLAN WITH DHA & FEMORAL GUIDE) WERE EMPLOYED AS ASSISTIVE TECHNOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406082 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD 1250-0100 STA_JI_10868

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention