BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9901928 · Received March 30, 2020

    Report

    Report Number
    3012916784-2020-00056
    Event Type
    Injury
    Date Received
    March 30, 2020
    Date of Event
    February 27, 2020
    Report Date
    June 13, 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, PATIENT SPECIFIC VISUALISATION REPORT, PRE-IMAGING, OPS ACETABULAR & FEMORAL GUIDES. ALL MANUFACTURING STEPS OF IMPLANT POSITIONING AND REPORT GENERATION WERE REVIEWED. RESULTS: . WITHOUT POST-OPERATIVE IMAGING OF THE PATIENT OR MORE INFORMATION ON THE NATURE AND LOCATION OF THE PAIN IT IS NOT POSSIBLE TO DETERMINE THE CAUSE. THERE WAS NO DETECTABLE ISSUE IN THE PLANNING OF THE ACETABULAR CUP OR ITS RESPECTIVE GUIDE WHICH WOULD CAUSE PAIN, THE CUP WAS APPROPRIATELY SIZED AND SHOWED NO SIGNS OF ANTERIOR CUP UNCOVERAGE AFTER ORIENTATION SELECTION. THE ONLY POTENTIAL ISSUE DETECTED WITH THE STEM PLANNING WAS ITS SIZE, HOWEVER THE SURGEON CHOSE TO INTRAOPERATIVELY DIVERGE FROM PLANNING BY DOWNSIZING THE IMPLANT (FROM SIZE 5 TO SIZE 4). IT IS POSSIBLE THAT CHANGING STEM CAN ADVERSELY AFFECT STEM POSITIONING, ALTHOUGH WITHOUT ANY POSTOPERATIVE IMAGING IT IS NOT POSSIBLE TO DETERMINE THIS. CONCLUSION: ALL OPERATIONS WERE COMPLETED CORRECTLY ACCORDING TO THE WORK INSTRUCTIONS. WITH THE INFORMATION SUPPLIED IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE PROBLEM. IT IS LIKELY THAT THE PATIENT SUFFERED PAIN DUE TO PATIENT- SPECIFIC FACTORS. 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

    PATIENT UNDERWENT PRIMARY PROCEDURE FOR THA IN (B)(6) 2018. PATIENT HAS RECENTLY COMPLAINED OF SIGNICANT PAIN. THEREFORE, PATIENT UNDERWENT REVISION PROCEDURE ON (B)(6) 2020. DURING PRIMARY PROCEDURE , OPS TECHNOLOGY (OPS PLAN WITH DHA & ACETABULAR GUIDE AND 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

    PATIENT UNDERWENT PRIMARY PROCEDURE FOR THA IN (B)(6) 2018. PATIENT HAS RECENTLY COMPLAINED OF SIGNIFICANT PAIN. THEREFORE, PATIENT UNDERWENT REVISION PROCEDURE ON (B)(6) 2020. DURING PRIMARY PROCEDURE , OPS TECHNOLOGY (OPS PLAN WITH DHA & ACETABULAR GUIDE AND FEMORAL GUIDE) WERE EMPLOYED AS ASSISTIVE TECHNOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363831 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD 1248-0500 RUS_MB_10625

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention