BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9440933 · Received December 9, 2019

    Report

    Report Number
    3012916784-2019-00027
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Date of Event
    November 14, 2019
    Report Date
    January 13, 2020
    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 NOT FIT WELL ON THE PATIENT'S FEMORAL HEAD. 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 FROM THE REPORTER WAS NOT ABLE TO BE PROVIDED. AS PART OF THE ROOT CAUSE INVESTIGATION INTO THIS ISSUE, THE PRE-OPERATIVE IMAGING FOR THIS PATIENT WAS REVIEWED BY OPTIMIZED ORTHO'S CHIEF MEDICAL OFFICER AND IT WAS FOUND THE PROGRESSION OF DISEASE WAS LIKELY TO LEAD TO THE COLLAPSE OF THE FEMORAL HEAD, WHICH WOULD HAVE LED TO A CHANGE IN PATIENT ANATOMY BETWEEN THE DATE OF IMAGING AND SURGERY. THE CASE PROCESSING OF THIS PRE-OPERATIVE PLANNING WAS REVIEWED AND IT WAS FOUND THAT ALL PRODUCTS PROVIDED WERE MANUFACTURED TO SPECIFICATION. THE ROOT CAUSE OF THIS ISSUE WAS DETERMINED TO BE PATIENT-SPECIFIC ISSUES. 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 NOT FIT WELL ON THE PATIENT'S FEMORAL HEAD. 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 FROM THE REPORTER WAS NOT ABLE TO BE PROVIDED. AS PART OF THE ROOT CAUSE INVESTIGATION INTO THIS ISSUE, THE PRE-OPERATIVE IMAGING FOR THIS PATIENT WAS REVIEWED BY OPTIMIZED ORTHO'S CHIEF MEDICAL OFFICER AND IT WAS FOUND THE PROGRESSION OF DISEASE WAS LIKELY TO LEAD TO THE COLLAPSE OF THE FEMORAL HEAD, WHICH WOULD HAVE LED TO A CHANGE IN PATIENT ANATOMY BETWEEN THE DATE OF IMAGING AND SURGERY. THE CASE PROCESSING OF THIS PRE-OPERATIVE PLANNING WAS REVIEWED AND IT WAS FOUND THAT ALL PRODUCTS PROVIDED WERE MANUFACTURED TO SPECIFICATION. THE ROOT CAUSE OF THIS ISSUE WAS DETERMINED TO BE PATIENT-SPECIFIC ISSUES. 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 NOT FIT WELL ON THE PATIENT'S FEMORAL HEAD. 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 NOT FIT WELL ON THE PATIENT'S FEMORAL HEAD. 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
    1237081 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD 1250-1100 ZAI_DR_19263

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR