BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 8614287 · Received May 15, 2019

    Report

    Report Number
    3012916784-2019-00015
    Event Type
    Malfunction
    Date Received
    May 15, 2019
    Date of Event
    April 11, 2019
    Report Date
    June 14, 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 · 0

    CC-248 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 SUB-OPTIMAL FOR THE PATIENT. THIS MAY AFFECT THE CUP PLACEMENT, POSING A RISK OF SUBSEQUENT PATIENT RE-INTERVENTION. A ROOT CAUSE ANALYSIS HAS NOW BEEN CONDUCTED INTO THIS EVENT. 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. 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. NO FURTHER CORRECTIVE OR PREVENTATIVE ACTION WILL BE TAKEN AT THIS TIME. 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'SREPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    CC-248 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 SUB-OPTIMAL FOR THE PATIENT. THIS MAY AFFECT THE CUP PLACEMENT, POSING A RISK OF SUBSEQUENT PATIENT RE-INTERVENTION. THE DYNAMIC HIP ANALYSIS (DHA) REPORT IS NOT AVAILABLE ON THE US MARKET, HOWEVER THE FUNCTIONAL HIP ANALYSIS (FHA) REPORT WHICH ALSO EMPLOYS THE USE OF THESE FUNCTIONAL X-RAYS IS CLEARED BY THE FDA.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 SUB-OPTIMAL FOR THE PATIENT. THIS MAY AFFECT THE CUP PLACEMENT, POSING A RISK OF SUBSEQUENT PATIENT RE-INTERVENTION. 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). 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 SUB-OPTIMAL FOR THE PATIENT. THIS MAY AFFECT THE CUP PLACEMENT, POSING A RISK OF SUBSEQUENT PATIENT RE-INTERVENTION. THE DYNAMIC HIP ANALYSIS (DHA) REPORT IS NOT AVAILABLE ON THE US MARKET, HOWEVER THE FUNCTIONAL HIP ANALYSIS (FHA) REPORT WHICH ALSO EMPLOYS THE USE OF THESE FUNCTIONAL X-RAYS IS CLEARED BY THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403972 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD N/A WOO_SG_16510

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR