BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9462078 · Received December 12, 2019

    Report

    Report Number
    3012916784-2019-00038
    Event Type
    Malfunction
    Date Received
    December 12, 2019
    Date of Event
    December 9, 2019
    Report Date
    January 22, 2020
    Manufacturer
    OPTIMIZED ORTHO PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    K152893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT, THAT THE PATIENT SPECIFIC FEMORAL GUIDES (K181061) AND PATIENT SPECIFIC ACETABULAR GUIDES (K152893) WERE PACKED IN THE INCORRECT BOX FOR THE PATIENTS THE GUIDES WERE DESIGNED FOR, RESULTING IN THE INCORRECT PATIENT SPECIFIC GUIDES BEING SENT TO THE SURGERIES. THIS ISSUE IS CONSIDERED IN THE PRODUCT RISK ASSESSMENT TO BE A RISK OF ADVERSE EVENT TO THE PATIENT. IF THE WRONG GUIDE IS DELIVERED TO THE HOSPITAL WHICH COULD LEAD TO INCORRECT OSTEOTOMY LEVEL RESECTION AND SUB-OPTIMAL ORIENTATION OF THE CUP AS THE PATIENT MAY RECEIVE THE USE OF PATIENT SPECIFIC GUIDES NOT INTENDED FOR THEM, WHICH MAY RESULT IN PATIENT HIP PAIN OR GAIT PROBLEMS. THIS ISSUE WAS DETECTED PRIOR TO THE POINT OF USE OF THE DEVICES AND IMMEDIATE CORRECTION WAS TAKEN. THE PARTS DELIVERED TO THE WRONG SURGERY WERE REQUESTED FOR CORRECTED DELIVERY. FURTHER DETAILS REGARDING THE RESULTS OF THIS CORRECTION WILL BE INCLUDED IN A FOLLOW UP REPORT. IT WAS CONFIRMED THAT NEITHER SET OF PATIENT SPECIFIC GUIDES WERE ABLE TO BE CORRECTLY DELIVERED BEFORE SURGERY. IT WAS DETERMINED THAT THIS ISSUE IS THE RESULT OF THE PATIENT SPECIFIC PARTS BEING INSPECTED AND THEN PLACED IN THE INCORRECT BOXES BY MISTAKE. THE INSPECTION RECORDS FOR THESE PARTS WERE RETRIEVED AND REVIEWED, AND IT WAS CONFIRMED THAT THE INSPECTION OF THESE PARTS WAS COMPLETED CORRECTLY BY QUALIFIED ENGINEERS. THE ROOT CAUSE OF THIS ISSUE IS THEREFORE DETERMINED TO BE OPERATOR ERROR. THIS OCCURRENCE WAS DISCUSSED WITH THE OPS PRODUCTION TEAM LEADERS AND THE IMPORTANCE OF DILIGENCE DURING PARTS INSPECTION WAS REITERATED, AND A CLOSING SUMMARY OF THIS INVESTIGATION WAS SENT TO THE SURGEON REPRESENTATIVE TO PASS ON TO THE AFFECTED SURGEON WHO REQUESTED IT. 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

    THIS EVENT, THAT THE PATIENT SPECIFIC FEMORAL GUIDES (K181061) AND PATIENT SPECIFIC ACETABULAR GUIDES (K152893) WERE PACKED IN THE INCORRECT BOX FOR THE PATIENTS THE GUIDES WERE DESIGNED FOR, RESULTING IN THE INCORRECT PATIENT SPECIFIC GUIDES BEING SENT TO THE SURGERIES. THIS ISSUE IS CONSIDERED IN THE PRODUCT RISK ASSESSMENT TO BE A RISK OF ADVERSE EVENT TO THE PATIENT. IF THE WRONG GUIDE IS DELIVERED TO THE HOSPITAL WHICH COULD LEAD TO INCORRECT OSTEOTOMY LEVEL RESECTION AND SUB-OPTIMAL ORIENTATION OF THE CUP AS THE PATIENT MAY RECEIVE THE USE OF PATIENT SPECIFIC GUIDES NOT INTENDED FOR THEM, WHICH MAY RESULT IN PATIENT HIP PAIN OR GAIT PROBLEMS. THIS ISSUE WAS DETECTED PRIOR TO THE POINT OF USE OF THE DEVICES AND IMMEDIATE CORRECTION WAS TAKEN. THE PARTS DELIVERED TO THE WRONG SURGERY WERE REQUESTED FOR CORRECTED DELIVERY. FURTHER DETAILS REGARDING THE RESULTS OF THIS CORRECTION WILL BE INCLUDED IN A FOLLOW UP REPORT. IT WAS CONFIRMED THAT NEITHER SET OF PATIENT SPECIFIC GUIDES WERE ABLE TO BE CORRECTLY DELIVERED BEFORE SURGERY. IT WAS DETERMINED THAT THIS ISSUE IS THE RESULT OF THE PATIENT SPECIFIC PARTS BEING INSPECTED AND THEN PLACED IN THE INCORRECT BOXES BY MISTAKE. THE INSPECTION RECORDS FOR THESE PARTS WERE RETRIEVED AND REVIEWED, AND IT WAS CONFIRMED THAT THE INSPECTION OF THESE PARTS WAS COMPLETED CORRECTLY BY QUALIFIED ENGINEERS. THE ROOT CAUSE OF THIS ISSUE IS THEREFORE DETERMINED TO BE OPERATOR ERROR. THIS OCCURRENCE WAS DISCUSSED WITH THE OPS PRODUCTION TEAM LEADERS AND THE IMPORTANCE OF DILIGENCE DURING PARTS INSPECTION WAS REITERATED, AND A CLOSING SUMMARY OF THIS INVESTIGATION WAS SENT TO THE SURGEON REPRESENTATIVE TO PASS ON TO THE AFFECTED SURGEON WHO REQUESTED IT. 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

    THIS EVENT, THAT THE PATIENT SPECIFIC FEMORAL GUIDES (K181061) AND PATIENT SPECIFIC ACETABULAR GUIDES (K152893) WERE PACKED IN THE INCORRECT BOX FOR THE PATIENTS THE GUIDES WERE DESIGNED FOR, RESULTING IN THE INCORRECT PATIENT SPECIFIC GUIDES BEING SENT TO THE SURGERIES. THIS ISSUE IS CONSIDERED IN THE PRODUCT RISK ASSESSMENT TO BE A RISK OF ADVERSE EVENT TO THE PATIENT. IF THE WRONG GUIDE IS DELIVERED TO THE HOSPITAL WHICH COULD LEAD TO INCORRECT OSTEOTOMY LEVEL RESECTION AND SUB-OPTIMAL ORIENTATION OF THE CUP AS THE PATIENT MAY RECEIVE THE USE OF PATIENT SPECIFIC GUIDES NOT INTENDED FOR THEM, WHICH MAY RESULT IN PATIENT HIP PAIN OR GAIT PROBLEMS. THIS ISSUE WAS DETECTED PRIOR TO THE POINT OF USE OF THE DEVICES AND IMMEDIATE CORRECTION WAS TAKEN. THE PARTS DELIVERED TO THE WRONG SURGERY WERE REQUESTED FOR CORRECTED DELIVERY. FURTHER DETAILS REGARDING THE RESULTS OF THIS CORRECTION WILL BE INCLUDED IN A FOLLOW UP REPORT. 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

    THIS EVENT, THAT THE PATIENT SPECIFIC FEMORAL GUIDES (K181061) AND PATIENT SPECIFIC ACETABULAR GUIDES (K152893) WERE PACKED IN THE INCORRECT BOX FOR THE PATIENTS THE GUIDES WERE DESIGNED FOR, RESULTING IN THE INCORRECT PATIENT SPECIFIC GUIDES BEING SENT TO THE SURGERIES. THIS ISSUE IS CONSIDERED IN THE PRODUCT RISK ASSESSMENT TO BE A RISK OF ADVERSE EVENT TO THE PATIENT. IF THE WRONG GUIDE IS DELIVERED TO THE HOSPITAL WHICH COULD LEAD TO INCORRECT OSTEOTOMY LEVEL RESECTION AND SUB-OPTIMAL ORIENTATION OF THE CUP AS THE PATIENT MAY RECEIVE THE USE OF PATIENT SPECIFIC GUIDES NOT INTENDED FOR THEM, WHICH MAY RESULT IN PATIENT HIP PAIN OR GAIT PROBLEMS. THIS ISSUE WAS DETECTED PRIOR TO THE POINT OF USE OF THE DEVICES AND IMMEDIATE CORRECTION WAS TAKEN. THE PARTS DELIVERED TO THE WRONG SURGERY WERE REQUESTED FOR CORRECTED DELIVERY. FURTHER DETAILS REGARDING THE RESULTS OF THIS CORRECTION WILL BE INCLUDED IN A FOLLOW UP REPORT. 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
    1257990 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD 1248-1500 HAN_VM_19965

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR