BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9068889 · Received September 16, 2019

    Report

    Report Number
    3012916784-2019-00019
    Event Type
    Malfunction
    Date Received
    September 16, 2019
    Date of Event
    August 20, 2019
    Report Date
    September 16, 2019
    Manufacturer
    OPTIMIZED ORTHO PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) COMBINED INITIAL AND FINAL REPORT. THE DYNAMIC HIP ANALYSIS (DHA) REPORT WAS GENERATED WITH AN INCORRECT LANDMARK; THE L1 LANDMARK WAS INSTEAD TAKEN FROM THE T12. THE ISSUE WAS DETECTED PRIOR TO USE ON (B)(6) 2019. THE CASE WAS REPROCESSED CORRECTLY. THE FUNCTIONAL X-RAYS USED TO GENERATE THE DHA REPORT ARE USED TO SIMULATE THE PATIENT'S SPINOPELVIC MOBILITY WHICH IS THEN UTILIZED TO CALCULATE THE CONTACT PATCH. IF THE INCORRECT L1 LANDMARK IS TAKEN, THE CALCULATION OF THE LUMBAR LORDOSIS ANGLE WILL BE INCORRECT, LEADING TO AN INCORRECT CALCULATION OF THE CONTACT PATCH. THIS HAS THE POTENTIAL TO AFFECT THE SURGEON'S SELECTION OF THE OPTIMAL CUP ORIENTATION FOR THAT PATIENT. THE OPS ACETABULAR GUIDE MIGHT BE DESIGNED BASED ON THIS SELECTED ORIENTATION WHICH MAY BE SUBOPTIMAL FOR THE PATIENT. THIS MAY AFFECT THE CUP PLACEMENT, POSING A RISK OF SUBSEQUENT PATIENT RE-INTERVENTION. THE ISSUE WAS DETECTED PRIOR TO THE POINT OF USE OF THE DEVICE AND THERE WAS NO CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THIS ISSUE. THE REPORT WAS REPROCESSED AND CORRECTED PRIOR TO USE. THE ISSUE WAS DISCUSSED WITH THE OPS ENGINEERS. THIS ISSUE WILL BE CONTINUED TO BE MONITORED FOR FUTURE REOCCURRENCE. THE DYNAMIC HIP ANALYSIS (DHA) REPORT IS NOT AVAILABLE ON THE US MARKET, HOWEVER THE FUNCTIONAL HIP ANALYSIS (FHA) REPORT (K152893) WHICH ALSO EMPLOYS THE USE OF THESE FUNCTIONAL X-RAYS IS CLEARED BY THE FDA. 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

    (B)(4) COMBINED INITIAL AND FINAL REPORT. THE DYNAMIC HIP ANALYSIS (DHA) REPORT WAS GENERATED WITH AN INCORRECT LANDMARK; THE L1 LANDMARK WAS INSTEAD TAKEN FROM THE T12. THE ISSUE WAS DETECTED PRIOR TO USE ON (B)(6) 2019. THE CASE WAS REPROCESSED CORRECTLY. THE FUNCTIONAL X-RAYS USED TO GENERATE THE DHA REPORT ARE USED TO SIMULATE THE PATIENT'S SPINOPELVIC MOBILITY WHICH IS THEN UTILIZED TO CALCULATE THE CONTACT PATCH. IF THE INCORRECT L1 LANDMARK IS TAKEN, THE CALCULATION OF THE LUMBAR LORDOSIS ANGLE WILL BE INCORRECT, LEADING TO AN INCORRECT CALCULATION OF THE CONTACT PATCH. THIS HAS THE POTENTIAL TO AFFECT THE SURGEON'S SELECTION OF THE OPTIMAL CUP ORIENTATION FOR THAT PATIENT. THE OPS ACETABULAR GUIDE MIGHT BE DESIGNED BASED ON THIS SELECTED ORIENTATION WHICH MAY BE SUBOPTIMAL FOR THE PATIENT. THIS MAY AFFECT THE CUP PLACEMENT, POSING A RISK OF SUBSEQUENT PATIENT RE-INTERVENTION. THE ISSUE WAS DETECTED PRIOR TO THE POINT OF USE OF THE DEVICE AND THERE WAS NO CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THIS ISSUE. THE REPORT WAS REPROCESSED AND CORRECTED PRIOR TO USE. THE ISSUE WAS DISCUSSED WITH THE OPS ENGINEERS. THIS ISSUE WILL BE CONTINUED TO BE MONITORED FOR FUTURE REOCCURRENCE. THE DYNAMIC HIP ANALYSIS (DHA) REPORT IS NOT AVAILABLE ON THE US MARKET, HOWEVER THE FUNCTIONAL HIP ANALYSIS (FHA) REPORT (K152893) WHICH ALSO EMPLOYS THE USE OF THESE FUNCTIONAL X-RAYS IS CLEARED BY THE FDA. 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
    868097 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS, PRODUCT CODE: LZO LZO OPTIMIZED ORTHO PTY LTD N/A YOU_EO_18448

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR