BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9614402 · Received January 21, 2020

    Report

    Report Number
    3012916784-2020-00045
    Event Type
    Malfunction
    Date Received
    January 21, 2020
    Date of Event
    January 8, 2020
    Report Date
    May 6, 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

    METHOD: NO COMPLAINT DEVICES WERE RETURNED TO OPTIMIZED ORTHO BY THE CUSTOMER. THUS, THE DEVICE HISTORY LES WERE INVESTIGATED WHICH INCLUDED REVIEWING THE OPS FEMORAL GUIDE DESIGN, PRE-OPERATIVE IMAGING ALL PRODUCTION STEPS OF THE FEMORAL GUIDE. RESULTS: THE FEMORAL GUIDE WAS DESIGNED TO THE CORRECT PRODUCTION PROCESS, ADHERING TO THE RELEVANT PROCEDURES AND WORK INSTRUCTIONS. THE SEGMENTATION AND LAND MARKING WAS ACCURATE. THE IMPLANT POSITIONING WAS WITHIN SPECICATIONS. AS IT HAS BEEN DETERMINED THAT THE PRODUCTS INVOLVED IN THIS COMPLAINT ACCURATELY AND CORRECTLY FOLLOWED THE STEPS LAID OUT IN THE RELEVANT PROCEDURES. IT IS LIKELY THAT THE ROOT CAUSE OF THIS CUSTOMER COMPLAINT WAS OUT OF THE CONTROL OF INTERNAL PROCESS, AND COULD HAVE BEEN A RESULT OF FACTORS SUCH AS POOR PLACEMENT OF THE FEMORAL GUIDE ON THE FEMUR INTRA-OPERATIVELY. CONCLUSION: THE FEMORAL GUIDE FOR THIS CASE WAS GENERATED CORRECTLY AND WAS WITHIN ALL SPECICATIONS AS DESCRIBED IN INTERNAL PROCEDURES. IT WAS FOUND THAT THE LIKELY ROOT CAUSE OF THIS CUSTOMER COMPLAINT WAS OUT OF THE CONTROL OF INTERNAL PROCESSES. 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 BE POOR FITTING. THE SURGEON PROCEEDED WITH THE USE OF THE GUIDE AND MADE ADJUSTMENTS TO COMPENSATE FOR POOR FIT. INFORMATION PROVIDED WITH THE PATIENT SPECIFIC GUIDES INDICATE FOR SURGEONS TO ABANDON THE USE OF THE GUIDES IF THEY DO NOT FIT. THERE IS NO EVIDENCE THAT FURTHER INTERVENTION HAS BEEN REQUIRED FOR THIS PATIENT. ADDITIONAL INFORMATION, INCLUDING A POST-OPERATIVE CT IMAGING OF THE HIP 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.

    Additional Manufacturer Narrative · 1

    THE PATIENT SPECIFIC FEMORAL GUIDE (K181061) WAS REPORTED TO BE POOR FITTING. THE SURGEON PROCEEDED WITH THE USE OF THE GUIDE AND MADE ADJUSTMENTS TO COMPENSATE FOR POOR FIT. INFORMATION PROVIDED WITH THE PATIENT SPECIFIC GUIDES INDICATE FOR SURGEONS TO ABANDON THE USE OF THE GUIDES IF THEY DO NOT FIT. THERE IS NO EVIDENCE THAT FURTHER INTERVENTION HAS BEEN REQUIRED FOR THIS PATIENT. ADDITIONAL INFORMATION, INCLUDING A POST-OPERATIVE CT IMAGING OF THE HIP 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 BE POOR FITTING. THE SURGEON PROCEEDED WITH THE USE OF THE GUIDE AND MADE ADJUSTMENTS TO COMPENSATE FOR POOR FIT. INFORMATION PROVIDED WITH THE PATIENT SPECIFIC GUIDES INDICATE FOR SURGEONS TO ABANDON THE USE OF THE GUIDES IF THEY DO NOT FIT. THERE IS NO EVIDENCE THAT FURTHER INTERVENTION HAS BEEN REQUIRED FOR THIS PATIENT. ADDITIONAL INFORMATION, INCLUDING A POST-OPERATIVE CT IMAGING OF THE HIP 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
    77417 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD 1250-1100 CLO_AS_20667

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR