BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9462295 · Received December 12, 2019

    Report

    Report Number
    3012916784-2019-00039
    Event Type
    Malfunction
    Date Received
    December 12, 2019
    Date of Event
    December 2, 2019
    Report Date
    January 15, 2020
    Manufacturer
    OPTIMIZED ORTHO PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    K152893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT SPECIFIC ACETABULAR GUIDE (K152893) WAS REPORTED TO BE POOR FITTING AND UNSTABLE IN THE PATIENT'S ACETABULUM. THIS RISK IS DETERMINED TO POTENTIALLY LEAD TO AN ADVERSE EVENT FOR THE PATIENT, AS THIS MAY LEAD TO PATIENT SPECIFIC INSTRUMENT MAY DELIVER A SUB-OPTIMAL ACETABULAR ORIENTATION, RESULTING IN HIP PAIN OR GAIT PROBLEMS. IN THIS CASE, NO ADVERSE EVENT WAS REPORTED TO RESULT FROM THIS ISSUE. IT WAS UNABLE TO BE CONFIRMED IF THE USE OF THE ACETABULAR GUIDE WAS ABANDONED AS A RESULT OF THIS ISSUE. FURTHER DETAILS HAVE BEEN REQUESTED FROM THE SURGEON REPRESENTATIVE AND WILL BE PROVIDED IN A FOLLOW UP REPORT. IT WAS CONFIRMED THAT THE SURGEON ABANDONED THE USE OF THE ACETABULAR GUIDE AS A RESULT OF THIS ISSUE. A ROOT CAUSE INVESTIGATION HAS BEEN CONDUCTED IN THIS EVENT. POTENTIAL SOURCES OF INSTABILITY WERE INVESTIGATED, INCLUDING PATIENT ANATOMY, IMAGING QUALITY, GUIDE DESIGN, AND SEGMENTATION OF IMAGING. THE CT IMAGING USED TO CREATE THE GUIDE WAS REPORTED TO BE OF GOOD QUALITY, HOWEVER THE FOSSA WAS SEVERELY FLATTENED WHICH ADVERSELY AFFECTED THE STABILITY OF THE ACETABULAR GUIDE. THE DATE OF IMAGING WAS (B)(6) 2019, AND IT WAS DETERMINED TO BE POSSIBLE BUT UNLIKELY THAT THE PATIENT'S ACETABULAR ANATOMY HAD DEGRADED FURTHER BETWEEN THE DATE OF IMAGING AND SURGERY. THE ACETABULAR GUIDE WAS DESIGNED IN ACCORDANCE WITH THE SURGEON PREFERENCE WHICH AT THE TIME INDICATED FOR AN ANTERIOR "IN-ARM" AND A POSTERIOR "WIDE AT RIM ARM" WITH AN INFERIOR HOOK ON THE THUMB IF NECESSARY. THE ENGINEER DESIGNING THE GUIDE IDENTIFIED THAT DUE TO THE POOR FOSSA DEFINITION, A STANDARD THUMB WOULD BE LIKELY TO BE UNSTABLE AND SO AN INFERIOR HOOK WAS ADDED TO INCREASE STABILITY. AN ANTERIOR "WIDE AT RIM ARM" WAS CONSIDERED AND DECIDED AGAINST AS IT WOULD DEVIATE FROM THE SURGEON'S PREFERENCES. AS THE GUIDE WAS PRINTED IN THE US AT OUR EXTERNAL SUPPLIER, OUR OPS PRODUCTION ENGINEERS DID NOT HAVE THE OPPORTUNITY TO INSPECT IT AND IDENTIFY THE INSTABILITY BEFORE IT WAS SHIPPED TO THE SURGEON. THE GUIDE PASSED OUR EXTERNAL SUPPLIER'S INSPECTIONS PROTOCOLS WITH NO NOTES OR COMMENTS. THE CONCLUSION OF THIS INVESTIGATION SHOWED THAT THE SURGEON'S PREFERENCES HAVE SINCE BEEN UPDATED, AND IT WAS DETERMINED THAT IF A PATIENT WITH SIMILAR ANATOMY IS ENCOUNTERED IN THE FUTURE, THE ANTERIOR "IN-ARM" WOULD BE CHANGED TO A "WIDE AT RIM ARM", WHICH WOULD BE EXPECTED TO INCREASE GUIDE STABILITY. 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 PATIENT SPECIFIC ACETABULAR GUIDE (K152893) WAS REPORTED TO BE POOR FITTING AND UNSTABLE IN THE PATIENT'S ACETABULUM. THIS RISK IS DETERMINED TO POTENTIALLY LEAD TO AN ADVERSE EVENT FOR THE PATIENT, AS THIS MAY LEAD TO PATIENT SPECIFIC INSTRUMENT MAY DELIVER A SUB-OPTIMAL ACETABULAR ORIENTATION, RESULTING IN HIP PAIN OR GAIT PROBLEMS. IN THIS CASE, NO ADVERSE EVENT WAS REPORTED TO RESULT FROM THIS ISSUE. IT WAS UNABLE TO BE CONFIRMED IF THE USE OF THE ACETABULAR GUIDE WAS ABANDONED AS A RESULT OF THIS ISSUE. FURTHER DETAILS HAVE BEEN REQUESTED FROM THE SURGEON REPRESENTATIVE AND WILL BE PROVIDED IN A FOLLOW UP REPORT. IT WAS CONFIRMED THAT THE SURGEON ABANDONED THE USE OF THE ACETABULAR GUIDE AS A RESULT OF THIS ISSUE. A ROOT CAUSE INVESTIGATION HAS BEEN CONDUCTED IN THIS EVENT. POTENTIAL SOURCES OF INSTABILITY WERE INVESTIGATED, INCLUDING PATIENT ANATOMY, IMAGING QUALITY, GUIDE DESIGN, AND SEGMENTATION OF IMAGING. THE CT IMAGING USED TO CREATE THE GUIDE WAS REPORTED TO BE OF GOOD QUALITY, HOWEVER THE FOSSA WAS SEVERELY FLATTENED WHICH ADVERSELY AFFECTED THE STABILITY OF THE ACETABULAR GUIDE. THE DATE OF IMAGING WAS (B)(6) 2019, AND IT WAS DETERMINED TO BE POSSIBLE BUT UNLIKELY THAT THE PATIENT'S ACETABULAR ANATOMY HAD DEGRADED FURTHER BETWEEN THE DATE OF IMAGING AND SURGERY. THE ACETABULAR GUIDE WAS DESIGNED IN ACCORDANCE WITH THE SURGEON PREFERENCE WHICH AT THE TIME INDICATED FOR AN ANTERIOR "IN-ARM" AND A POSTERIOR "WIDE AT RIM ARM" WITH AN INFERIOR HOOK ON THE THUMB IF NECESSARY. THE ENGINEER DESIGNING THE GUIDE IDENTIFIED THAT DUE TO THE POOR FOSSA DEFINITION, A STANDARD THUMB WOULD BE LIKELY TO BE UNSTABLE AND SO AN INFERIOR HOOK WAS ADDED TO INCREASE STABILITY. AN ANTERIOR "WIDE AT RIM ARM" WAS CONSIDERED AND DECIDED AGAINST AS IT WOULD DEVIATE FROM THE SURGEON'S PREFERENCES. AS THE GUIDE WAS PRINTED IN THE US AT OUR EXTERNAL SUPPLIER, OUR OPS PRODUCTION ENGINEERS DID NOT HAVE THE OPPORTUNITY TO INSPECT IT AND IDENTIFY THE INSTABILITY BEFORE IT WAS SHIPPED TO THE SURGEON. THE GUIDE PASSED OUR EXTERNAL SUPPLIER'S INSPECTIONS PROTOCOLS WITH NO NOTES OR COMMENTS. THE CONCLUSION OF THIS INVESTIGATION SHOWED THAT THE SURGEON'S PREFERENCES HAVE SINCE BEEN UPDATED, AND IT WAS DETERMINED THAT IF A PATIENT WITH SIMILAR ANATOMY IS ENCOUNTERED IN THE FUTURE, THE ANTERIOR "IN-ARM" WOULD BE CHANGED TO A "WIDE AT RIM ARM", WHICH WOULD BE EXPECTED TO INCREASE GUIDE STABILITY.

    Additional Manufacturer Narrative · 1

    THE PATIENT SPECIFIC ACETABULAR GUIDE (K152893) WAS REPORTED TO BE POOR FITTING AND UNSTABLE IN THE PATIENT'S ACETABULUM. THIS RISK IS DETERMINED TO POTENTIALLY LEAD TO AN ADVERSE EVENT FOR THE PATIENT, AS THIS MAY LEAD TO PATIENT SPECIFIC INSTRUMENT MAY DELIVER A SUB-OPTIMAL ACETABULAR ORIENTATION, RESULTING IN HIP PAIN OR GAIT PROBLEMS. IN THIS CASE, NO ADVERSE EVENT WAS REPORTED TO RESULT FROM THIS ISSUE. IT WAS UNABLE TO BE CONFIRMED IF THE USE OF THE ACETABULAR GUIDE WAS ABANDONED AS A RESULT OF THIS ISSUE. FURTHER DETAILS HAVE BEEN REQUESTED FROM THE SURGEON REPRESENTATIVE AND WILL BE PROVIDED IN A FOLLOW UP REPORT. 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 · 1

    THE PATIENT SPECIFIC ACETABULAR GUIDE (K152893) WAS REPORTED TO BE POOR FITTING AND UNSTABLE IN THE PATIENT'S ACETABULUM. THIS RISK IS DETERMINED TO POTENTIALLY LEAD TO AN ADVERSE EVENT FOR THE PATIENT, AS THIS MAY LEAD TO PATIENT SPECIFIC INSTRUMENT MAY DELIVER A SUB-OPTIMAL ACETABULAR ORIENTATION, RESULTING IN HIP PAIN OR GAIT PROBLEMS. IN THIS CASE, NO ADVERSE EVENT WAS REPORTED TO RESULT FROM THIS ISSUE. IT WAS UNABLE TO BE CONFIRMED IF THE USE OF THE ACETABULAR GUIDE WAS ABANDONED AS A RESULT OF THIS ISSUE. FURTHER DETAILS HAVE BEEN REQUESTED FROM THE SURGEON REPRESENTATIVE AND WILL BE PROVIDED IN A FOLLOW UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257984 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD 1248-1500 DAH_JV_19655

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR