BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9640297 · Received January 28, 2020

    Report

    Report Number
    3012916784-2020-00051
    Event Type
    Malfunction
    Date Received
    January 28, 2020
    Date of Event
    December 4, 2019
    Report Date
    March 23, 2020
    Manufacturer
    OPTIMIZED ORTHO PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    K181061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    METHOD: OPS PLAN, OPS PLAN APPENDIX AND THE DEVICE HISTORY RECORD WERE INVESTIGATED. RESULTS: THE MAJORITY OF THE OPS PLAN WARNINGS ARE AUTOMATIC HOWEVER NOTES ADDED TO SPECIFIC TO IMPLANT POSITIONING SUCH AS THE NOTE APPLICABLE FOR THIS CASE WERE MANUAL AND NEEDED TO BE ENTERED MANUALLY. THE NOTE REQUIRED ON AN OPS PLAN FOR THE CUP PLANNING SHOULD HAVE BEEN ADDED TO THE NOTES SECTION OF THE OPS PLAN AND THEN SUBSEQUENTLY CHECKED BY THE ENGINEER AT THE NEXT PRODUCTION STEP. THIS WAS AN OVERSIGHT OF THE OPS ENGINEER AND SUBSEQUENT QUALITY CHECK ENGINEER DURING TWO DIFFERENT STAGES OF THE PRODUCTION (OP45 AND OP50). CONCLUSION: THE ISSUE OCCURRED AS A RESULT OF AN OPERATOR ERROR. HOWEVER, THE REPORTS WERE UPDATED AND UPLOADED ON THE PORTAL ACCESSIBLE TO THE SURGEON. NO ADVERSE EVENT OCCURRED AS A RESULT OF THIS ISSUE. 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

    THE ACETABULAR CUP IN THE PATIENT SPECIFIC PRE-OPERATIVE PLANNING HAD TO BE PLANNED OUTSIDE THE NORM DUE TO PATIENT SPECIFIC MORPHOLOGY, HOWEVER THE RELEVANT PATIENT SPECIFIC NOTE WAS NOT ADDED TO THE OPS PLAN REPORT (K181061). THIS ISSUE WAS DETECTED PRIOR TO THE POINT OF USE OF THE PRODUCT AND IMMEDIATE CORRECTION WAS MADE TO THE PRODUCT AND IT WAS RELEASED. THE RISK OF MISSING PATIENT SPECIFIC WARNINGS OR NOTES FROM THE ENGINEER IS CONSIDERED IN THE PRODUCT RISK ASSESSMENT (OPT-SK-13 REV10 FEM P161) TO BE A RISK OF THE SURGEON MISINTERPRETING THE PLAN, AND INCORRECT PRESCRIPTION OF THE PLAN, WHICH COULD LEAD TO THE PATIENT HAVING PAIN OR GAIT PROBLEMS.

    Additional Manufacturer Narrative · 1

    THE ACETABULAR CUP IN THE PATIENT SPECIFIC PRE-OPERATIVE PLANNING HAD TO BE PLANNED OUTSIDE THE NORM DUE TO PATIENT SPECIFIC MORPHOLOGY, HOWEVER THE RELEVANT PATIENT SPECIFIC NOTE WAS NOT ADDED TO THE OPS PLAN REPORT (K181061). THIS ISSUE WAS DETECTED PRIOR TO THE POINT OF USE OF THE PRODUCT AND IMMEDIATE CORRECTION WAS MADE TO THE PRODUCT AND IT WAS RELEASED. THE RISK OF MISSING PATIENT SPECIFIC WARNINGS OR NOTES FROM THE ENGINEER IS CONSIDERED IN THE PRODUCT RISK ASSESSMENT (OPT-SK-13 REV10 FEM P161) TO BE A RISK OF THE SURGEON MISINTERPRETING THE PLAN, AND INCORRECT PRESCRIPTION OF THE PLAN, WHICH COULD LEAD TO THE PATIENT HAVING PAIN OR GAIT PROBLEMS.

    Description of Event or Problem · 1

    THE ACETABULAR CUP IN THE PATIENT SPECIFIC PRE-OPERATIVE PLANNING HAD TO BE PLANNED OUTSIDE THE NORM DUE TO PATIENT SPECIFIC MORPHOLOGY, HOWEVER THE RELEVANT PATIENT SPECIFIC NOTE WAS NOT ADDED TO THE OPS PLAN REPORT (K181061). THIS ISSUE WAS DETECTED PRIOR TO THE POINT OF USE OF THE PRODUCT AND IMMEDIATE CORRECTION WAS MADE TO THE PRODUCT AND IT WAS RELEASED. THE RISK OF MISSING PATIENT SPECIFIC WARNINGS OR NOTES FROM THE ENGINEER IS CONSIDERED IN THE PRODUCT RISK ASSESSMENT (OPT-SK-13 REV10 FEM P161) TO BE A RISK OF THE SURGEON MISINTERPRETING THE PLAN, AND INCORRECT PRESCRIPTION OF THE PLAN, WHICH COULD LEAD TO THE PATIENT HAVING PAIN OR GAIT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103272 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD STE_TW_20134

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR