BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9399701 · Received December 3, 2019

    Report

    Report Number
    3012916784-2019-00026
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    November 11, 2019
    Report Date
    January 15, 2020
    Manufacturer
    CORIN AUSTRALIA PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    K181061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT SPECIFIC FEMORAL GUIDE (K181061) WAS REPORTED TO CUT ON THE LESSER TROCHANTER RATHER THAN THE ABOVE AS PLANNED. THE SURGEON CONTINUED WITH THE PROCEDURE USING THE FEMORAL GUIDE. 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 OSTEOTOMY LEVEL 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. THE POST-OPERATIVE IMAGING REQUESTED WAS NOT ABLE TO BE PROVIDED BY THE REPORTER IN AN APPROPRIATE FORMAT THAT WOULD ALLOW ACCURATE ANALYSIS. A ROOT CAUSE INVESTIGATION INTO HOW THIS EVENT OCCURRED HAS NOW BEEN CONDUCTED. THE RESULT OF THE INVESTIGATION REVIEWED THE SEGMENTATION OF THE CT IMAGING USED TO GENERATE THE PATIENT SPECIFIC GUIDE AND THE DESIGN OF THE GUIDE PRODUCED. THE SEGMENTATION OF CT IMAGING WAS DETERMINED TO BE DIFFICULT DUE TO LOW DENSITY OSTEOPHYTES ON THE POSTERIOR SIDE OF THE FEMORAL HEAD. THIS WAS DETERMINED TO HAVE POTENTIALLY LEAD TO THE FEMORAL GUIDE NOT FITTING CORRECTLY. THE DESIGN OF THE FEMORAL GUIDE WAS REVIEWED AS PART OF THIS INVESTIGATION AND IT WAS CONFIRMED THAT THE PART WAS MANUFACTURED TO SPECIFICATION AND SHOULD HAVE BEEN ABLE TO CUT ACCURATELY. AS A RESULT OF THIS, THE ROOT CAUSE OF THE ISSUE WAS FOUND TO BE THE OSTEOPHYTES WHICH WERE NOT INCLUDED IN THE SEGMENTATION OF THE PATIENT ANATOMY, THE RESULTS OF WHICH DETERMINE THE DESIGN OF THE FEMORAL GUIDE. THIS ISSUE WAS DETERMINED TO BE THE REST OF OPERATOR ERROR BY THE ENGINEER PERFORMING THE SEGMENTATION OF CT IMAGING. 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

    THE PATIENT SPECIFIC FEMORAL GUIDE (K181061) WAS REPORTED TO CUT ON THE LESSER TROCHANTER RATHER THAN THE ABOVE AS PLANNED. THE SURGEON CONTINUED WITH THE PROCEDURE USING THE FEMORAL GUIDE. 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 OSTEOTOMY LEVEL 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. THE POST-OPERATIVE IMAGING REQUESTED WAS NOT ABLE TO BE PROVIDED BY THE REPORTER IN AN APPROPRIATE FORMAT THAT WOULD ALLOW ACCURATE ANALYSIS. A ROOT CAUSE INVESTIGATION INTO HOW THIS EVENT OCCURRED HAS NOW BEEN CONDUCTED. THE RESULT OF THE INVESTIGATION REVIEWED THE SEGMENTATION OF THE CT IMAGING USED TO GENERATE THE PATIENT SPECIFIC GUIDE AND THE DESIGN OF THE GUIDE PRODUCED. THE SEGMENTATION OF CT IMAGING WAS DETERMINED TO BE DIFFICULT DUE TO LOW DENSITY OSTEOPHYTES ON THE POSTERIOR SIDE OF THE FEMORAL HEAD. THIS WAS DETERMINED TO HAVE POTENTIALLY LEAD TO THE FEMORAL GUIDE NOT FITTING CORRECTLY. THE DESIGN OF THE FEMORAL GUIDE WAS REVIEWED AS PART OF THIS INVESTIGATION AND IT WAS CONFIRMED THAT THE PART WAS MANUFACTURED TO SPECIFICATION AND SHOULD HAVE BEEN ABLE TO CUT ACCURATELY. AS A RESULT OF THIS, THE ROOT CAUSE OF THE ISSUE WAS FOUND TO BE THE OSTEOPHYTES WHICH WERE NOT INCLUDED IN THE SEGMENTATION OF THE PATIENT ANATOMY, THE RESULTS OF WHICH DETERMINE THE DESIGN OF THE FEMORAL GUIDE. THIS ISSUE WAS DETERMINED TO BE THE REST OF OPERATOR ERROR BY THE ENGINEER PERFORMING THE SEGMENTATION OF CT IMAGING. 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.

    Additional Manufacturer Narrative · 1

    THE PATIENT SPECIFIC FEMORAL GUIDE (K181061) WAS REPORTED TO CUT ON THE LESSER TROCHANTER RATHER THAN THE ABOVE AS PLANNED. THE SURGEON CONTINUED WITH THE PROCEDURE USING THE FEMORAL GUIDE. 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 OSTEOTOMY LEVEL 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

    THE PATIENT SPECIFIC FEMORAL GUIDE (K181061) WAS REPORTED TO CUT ON THE LESSER TROCHANTER RATHER THAN THE ABOVE AS PLANNED. THE SURGEON CONTINUED WITH THE PROCEDURE USING THE FEMORAL GUIDE. 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 OSTEOTOMY LEVEL 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
    1201650 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO CORIN AUSTRALIA PTY LTD 1250-1100 WIL_JL_19657

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR