BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9399558 · Received December 2, 2019

    Report

    Report Number
    3012916784-2019-00024
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    November 4, 2019
    Report Date
    December 3, 2019
    Manufacturer
    OPTIMIZED ORTHO PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    K181061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 PLANNED 10MM ABOVE. 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. A ROOT CAUSE INVESTIGATION INTO THIS ISSUE HAS BEEN CONDUCTED. THE POST-OPERATIVE AP PELVIC X-RAY REQUESTED WAS PROVIDED BY THE SURGEON REPRESENTATIVE AND ANALYSED. IT WAS DETERMINED THAT THE OSTEOTOMY LEVEL WAS 5.8MM LOWER THAN THE PLANNED OSTEOTOMY LEVEL. THE PRE-OPERATIVE PLANNING AND DESIGN OF THE PATIENT SPECIFIC FEMORAL GUIDE WERE REVIEWED AND ALL PRODUCTS PROVIDED WERE FOUND TO BE MANUFACTURED ACCORDING TO SPECIFICATION. NO ROOT CAUSE RELATED TO THE USE OF THE PATIENT SPECIFIC FEMORAL GUIDE COULD BE IDENTIFIED. 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 PLANNED 10MM ABOVE. 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. A ROOT CAUSE INVESTIGATION INTO THIS ISSUE HAS BEEN CONDUCTED. THE POST-OPERATIVE AP PELVIC X-RAY REQUESTED WAS PROVIDED BY THE SURGEON REPRESENTATIVE AND ANALYSED. IT WAS DETERMINED THAT THE OSTEOTOMY LEVEL WAS 5.8MM LOWER THAN THE PLANNED OSTEOTOMY LEVEL. THE PRE-OPERATIVE PLANNING AND DESIGN OF THE PATIENT SPECIFIC FEMORAL GUIDE WERE REVIEWED AND ALL PRODUCTS PROVIDED WERE FOUND TO BE MANUFACTURED ACCORDING TO SPECIFICATION. NO ROOT CAUSE RELATED TO THE USE OF THE PATIENT SPECIFIC FEMORAL GUIDE COULD BE IDENTIFIED. 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 WAS REPORTED TO CUT ON THE LESSER TROCHANTER RATHER THAN THE PLANNED 10MM ABOVE. 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. 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 FEMORAL GUIDE WAS REPORTED TO CUT ON THE LESSER TROCHANTER RATHER THAN THE PLANNED 10MM ABOVE. 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
    1193947 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD 1250-1100 SKY_EX_19903

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR