BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9399502 · Received December 2, 2019

    Report

    Report Number
    3012916784-2019-00022
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    October 29, 2019
    Report Date
    December 17, 2019
    Manufacturer
    OPTIMIZED ORTHO PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    K152893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT SPECIFIC OPS ACETABULAR GUIDE (K152893) WAS REPORTED TO NOT SIT IN THE PATIENT'S ACETABULUM ACCURATELY. THE SURGEON CONTINUED THE PROCEDURE USING OPS ACETABULAR GUIDE TO DETERMINE ACETABULAR ORIENTATION. FURTHERMORE, THE STEM PLANNED USING THE OPS PLAN (K183038) WAS REPORTED TO SIT 3MM ABOVE THE OSTEOTOMY LEVEL. THERE IS NO EVIDENCE THAT FURTHER INTERVENTION HAS BEEN REQUIRED FOR THIS PATIENT. ADDITIONAL INFORMATION, INCLUDING A POST-OPERATIVE A-P PELVIC X-RAY HAS BEEN REQUESTED FOR THIS PATIENT IN ORDER TO MEASURE THE ACETABULAR CUP ORIENTATION TO DETERMINE WHETHER THERE HAS BEEN ANY IMPACT TO THE PATIENT, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE 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. THE MANUFACTURER HAS NOW CONDUCTED A ROOT CAUSE INVESTIGATION INTO THIS ISSUE. WITH REGARDS TO THE REPORTED INSTABILITY OF THE PATIENT SPECIFIC ACETABULAR GUIDE POTENTIAL SOURCES OF INSTABILITY WERE INVESTIGATED, INCLUDING IMAGING QUALITY, GUIDE DESIGN, AND SEGMENTATION OF IMAGING. THE CT IMAGING USED TO CREATE THE GUIDE WAS REPORTED TO BE OF GOOD QUALITY, AND THE FOSSA WAS WELL DEFINED AND THE BONE QUALITY WHERE THE GUIDE'S ARMS WOULD SIT WAS GOOD. THE ACETABULAR GUIDE WAS DESIGNED IN ACCORDANCE WITH THE SURGEON PREFERENCE AND NO SOURCES OF INSTABILITY WERE IDENTIFIED. THE MOST LIKELY ROOT CAUSE OF THIS REPORTED INSTABILITY WAS THEREBY DETERMINED TO BE INSUFFICIENT CLEARING OF THE ACETABULUM PRIOR TO USE OF THE GUIDE. THE IMAGING QUALITY AND SEGMENTATION OF THIS IMAGING WAS REVIEWED TO IDENTIFY A ROOT CAUSE OF THE REPORTED DIFFERENCE BETWEEN THE PLANNING AND THE PATIENT'S ANATOMY. THE IMAGING WAS DETERMINED TO BE OF GOOD QUALITY AND NO ISSUES WERE FOUND WITH THE SEGMENTATION OF THIS IMAGING. NO OBVIOUS ROOT CAUSE FOR THIS ISSUE COULD BE IDENTIFIED. THE TEMPLATING OF THE PLANNED STEM WAS REVIEWED AS PART OF THIS INVESTIGATION TO DETERMINE THE ROOT CAUSE OF THE PLANNED STEM SITTING 3MM ABOVE THE OSTEOTOMY LEVEL. THE SECOND SMALLEST SIZE OF THE SURGEON'S CHOSEN FEMORAL STEM WAS TEMPLATED. THE SIZING OF THE STEM WAS FOUND TO BE REASONABLE, HOWEVER A SPECIFIC SURGEON PREFERENCE TO AIM FOR 15 DEGREES OF STEM VERSION MEANT THAT THE ENGINEER PLANNING THE CASE HAD TO OVER-ANTEVERT THE STEM AS THE NATIVE FEMORAL VERSION WAS 9 DEGREES. THIS MAY HAVE LED TO THE SIZE 1 NOT FITTING AS WELL AS IT WOULD HAVE WITHOUT THIS PREFERENCE. A SIZE 0 WAS TEMPLATED AS PART OF THIS INVESTIGATION AND IT WAS FOUND THAT IN THE TRANSVERSE PLANE THIS SIZE WOULD NOT HAVE BEEN PLANNED ACCORDING TO OUR SPECIFICATION AS IT WOULD HAVE BEEN TOO SMALL. THESE FINDINGS HAVE BEEN RELAYED TO THE REPORTER OF THE 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

    PATIENT SPECIFIC OPS ACETABULAR GUIDE (K152893) WAS REPORTED TO NOT SIT IN THE PATIENT'S ACETABULUM ACCURATELY. THE SURGEON CONTINUED THE PROCEDURE USING OPS ACETABULAR GUIDE TO DETERMINE ACETABULAR ORIENTATION. FURTHERMORE, THE STEM PLANNED USING THE OPS PLAN (K183038) WAS REPORTED TO SIT 3MM ABOVE THE OSTEOTOMY LEVEL. THERE IS NO EVIDENCE THAT FURTHER INTERVENTION HAS BEEN REQUIRED FOR THIS PATIENT. ADDITIONAL INFORMATION, INCLUDING A POST-OPERATIVE A-P PELVIC X-RAY HAS BEEN REQUESTED FOR THIS PATIENT IN ORDER TO MEASURE THE ACETABULAR CUP ORIENTATION TO DETERMINE WHETHER THERE HAS BEEN ANY IMPACT TO THE PATIENT, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE 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. THE MANUFACTURER HAS NOW CONDUCTED A ROOT CAUSE INVESTIGATION INTO THIS ISSUE. WITH REGARDS TO THE REPORTED INSTABILITY OF THE PATIENT SPECIFIC ACETABULAR GUIDE POTENTIAL SOURCES OF INSTABILITY WERE INVESTIGATED, INCLUDING IMAGING QUALITY, GUIDE DESIGN, AND SEGMENTATION OF IMAGING. THE CT IMAGING USED TO CREATE THE GUIDE WAS REPORTED TO BE OF GOOD QUALITY, AND THE FOSSA WAS WELL DEFINED AND THE BONE QUALITY WHERE THE GUIDE'S ARMS WOULD SIT WAS GOOD. THE ACETABULAR GUIDE WAS DESIGNED IN ACCORDANCE WITH THE SURGEON PREFERENCE AND NO SOURCES OF INSTABILITY WERE IDENTIFIED. THE MOST LIKELY ROOT CAUSE OF THIS REPORTED INSTABILITY WAS THEREBY DETERMINED TO BE INSUFFICIENT CLEARING OF THE ACETABULUM PRIOR TO USE OF THE GUIDE. THE IMAGING QUALITY AND SEGMENTATION OF THIS IMAGING WAS REVIEWED TO IDENTIFY A ROOT CAUSE OF THE REPORTED DIFFERENCE BETWEEN THE PLANNING AND THE PATIENT'S ANATOMY. THE IMAGING WAS DETERMINED TO BE OF GOOD QUALITY AND NO ISSUES WERE FOUND WITH THE SEGMENTATION OF THIS IMAGING. NO OBVIOUS ROOT CAUSE FOR THIS ISSUE COULD BE IDENTIFIED. THE TEMPLATING OF THE PLANNED STEM WAS REVIEWED AS PART OF THIS INVESTIGATION TO DETERMINE THE ROOT CAUSE OF THE PLANNED STEM SITTING 3MM ABOVE THE OSTEOTOMY LEVEL. THE SECOND SMALLEST SIZE OF THE SURGEON'S CHOSEN FEMORAL STEM WAS TEMPLATED. THE SIZING OF THE STEM WAS FOUND TO BE REASONABLE, HOWEVER A SPECIFIC SURGEON PREFERENCE TO AIM FOR 15 DEGREES OF STEM VERSION MEANT THAT THE ENGINEER PLANNING THE CASE HAD TO OVER-ANTEVERT THE STEM AS THE NATIVE FEMORAL VERSION WAS 9 DEGREES. THIS MAY HAVE LED TO THE SIZE 1 NOT FITTING AS WELL AS IT WOULD HAVE WITHOUT THIS PREFERENCE. A SIZE 0 WAS TEMPLATED AS PART OF THIS INVESTIGATION AND IT WAS FOUND THAT IN THE TRANSVERSE PLANE THIS SIZE WOULD NOT HAVE BEEN PLANNED ACCORDING TO OUR SPECIFICATION AS IT WOULD HAVE BEEN TOO SMALL. THESE FINDINGS HAVE BEEN RELAYED TO THE REPORTER OF THE ISSUE.

    Additional Manufacturer Narrative · 1

    PATIENT SPECIFIC OPS ACETABULAR GUIDE WAS REPORTED TO NOT SIT IN THE PATIENT'S ACETABULUM ACCURATELY. THE SURGEON CONTINUED THE PROCEDURE USING OPS ACETABULAR GUIDE TO DETERMINE ACETABULAR ORIENTATION. FURTHERMORE, THE STEM PLANNED USING THE OPS PLAN WAS REPORTED TO SIT 3MM ABOVE THE OSTEOTOMY LEVEL. THERE IS NO EVIDENCE THAT FURTHER INTERVENTION HAS BEEN REQUIRED FOR THIS PATIENT. ADDITIONAL INFORMATION, INCLUDING A POST-OPERATIVE A-P PELVIC X-RAY HAS BEEN REQUESTED FOR THIS PATIENT IN ORDER TO MEASURE THE ACETABULAR CUP ORIENTATION TO DETERMINE WHETHER THERE HAS BEEN ANY IMPACT TO THE PATIENT, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE 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 SPECIFIC OPS ACETABULAR GUIDE WAS REPORTED TO NOT SIT IN THE PATIENT'S ACETABULUM ACCURATELY. THE SURGEON CONTINUED THE PROCEDURE USING OPS ACETABULAR GUIDE TO DETERMINE ACETABULAR ORIENTATION. FURTHERMORE, THE STEM PLANNED USING THE OPS PLAN WAS REPORTED TO SIT 3MM ABOVE THE OSTEOTOMY LEVEL. THERE IS NO EVIDENCE THAT FURTHER INTERVENTION HAS BEEN REQUIRED FOR THIS PATIENT. ADDITIONAL INFORMATION, INCLUDING A POST-OPERATIVE A-P PELVIC X-RAY HAS BEEN REQUESTED FOR THIS PATIENT IN ORDER TO MEASURE THE ACETABULAR CUP ORIENTATION TO DETERMINE WHETHER THERE HAS BEEN ANY IMPACT TO THE PATIENT, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193715 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD 1248-1500 DAV_MD_18507

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR