BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9333556 · Received November 17, 2019

    Report

    Report Number
    3012916784-2019-00020
    Event Type
    Malfunction
    Date Received
    November 17, 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

    CC-364 COMBINED INITIAL AND FINAL REPORT. THE DYNAMIC HIP ANALYSIS (DHA) REPORT, WAS GENERATED WITH THE INCORRECT LEG USED IN STEP-UP X-RAY. THE ISSUE WAS DETECTED PRIOR TO USE ON (B)(6) 2019. IT WAS CORRECTED, AND THE REPORT WAS RESENT TO THE SURGEON. THE FUNCTIONAL X-RAYS USED TO GENERATE THE DHA REPORT ARE USED TO MEASURE MAXIMUM EXTENSION OF THE PATIENT'S PELVIS WHICH IS THEN UTILIZED TO CALCULATE THE CONTACT PATCH. IF THE WRONG STEP-UP X-RAY IS USED, THE CALCULATION OF THE CONTACT PATCH WILL BE BASED ON THE INCORRECT MAXIMUM EXTENSION, LEADING TO INCORRECT CALCULATION OF THE EDGE-LOADING. 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 INCORRECT LEG WAS RAISED DURING THE FUNCTIONAL X-RAYS TAKEN FOR THIS CASE. THE IMAGING PROVIDED FROM THE IMAGING CENTRE CONTAINED INCORRECT STEP-UP X-RAY. THE ERROR WAS NOT DETECTED DURING WHEN IMAGING WAS TRANSFERRED FROM THE IMAGING CENTRE TO THE MANUFACTURER, AND WAS INSTEAD DETECTED AFTER THE REPORT HAD BEEN SENT TO THE SURGEON. THIS WAS DUE TO OPERATOR ERROR. 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 IMAGING CENTRE WAS NOTIFIED OF THE ISSUE AND RETRAINING WAS PROVIDED ON THE CORRECT LEG TO BE RAISED AS PER IMAGING PROTOCOL. THE ISSUE WAS DISCUSSED WITH THE OPS ENGINEERS. THIS ISSUE WILL BE CONTINUED TO BE MONITORED FOR FUTURE REOCCURRENCE. A CAPA HAS BEEN RAISED TO FURTHER INVESTIGATE THE OCCURRENCES OF THIS ISSUE. 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. 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

    CC-364 COMBINED INITIAL AND FINAL REPORT. THE DYNAMIC HIP ANALYSIS (DHA) REPORT, WAS GENERATED WITH THE INCORRECT LEG USED IN STEP-UP X-RAY. THE ISSUE WAS DETECTED PRIOR TO USE ON (B)(6) 2019. IT WAS CORRECTED, AND THE REPORT WAS RESENT TO THE SURGEON. THE FUNCTIONAL X-RAYS USED TO GENERATE THE DHA REPORT ARE USED TO MEASURE MAXIMUM EXTENSION OF THE PATIENT'S PELVIS WHICH IS THEN UTILIZED TO CALCULATE THE CONTACT PATCH. IF THE WRONG STEP-UP X-RAY IS USED, THE CALCULATION OF THE CONTACT PATCH WILL BE BASED ON THE INCORRECT MAXIMUM EXTENSION, LEADING TO INCORRECT CALCULATION OF THE EDGE-LOADING. 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 INCORRECT LEG WAS RAISED DURING THE FUNCTIONAL X-RAYS TAKEN FOR THIS CASE. THE IMAGING PROVIDED FROM THE IMAGING CENTRE CONTAINED INCORRECT STEP-UP X-RAY. THE ERROR WAS NOT DETECTED DURING WHEN IMAGING WAS TRANSFERRED FROM THE IMAGING CENTRE TO THE MANUFACTURER, AND WAS INSTEAD DETECTED AFTER THE REPORT HAD BEEN SENT TO THE SURGEON. THIS WAS DUE TO OPERATOR ERROR. 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 IMAGING CENTRE WAS NOTIFIED OF THE ISSUE AND RETRAINING WAS PROVIDED ON THE CORRECT LEG TO BE RAISED AS PER IMAGING PROTOCOL. THE ISSUE WAS DISCUSSED WITH THE OPS ENGINEERS. THIS ISSUE WILL BE CONTINUED TO BE MONITORED FOR FUTURE REOCCURRENCE. A CAPA HAS BEEN RAISED TO FURTHER INVESTIGATE THE OCCURRENCES OF THIS ISSUE. 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
    1127785 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD N/A BAK_GS_19543

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR