BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMIZED POSITIONING SYSTEM (OPS) INSIGHT

    MDR report key: 10107643 · Received June 2, 2020

    Report

    Report Number
    3012916784-2020-00059
    Event Type
    Malfunction
    Date Received
    June 2, 2020
    Date of Event
    March 30, 2020
    Report Date
    July 8, 2020
    Manufacturer
    OPTIMIZED ORTHO PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    K192656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    METHOD: OPS INSIGHT PLANNING WAS REVIEWED AS PART OF THIS INVESTIGATION ALONG WITH PRE-OPERATIVE IMAGING. RESULTS: THE INCORRECT LEG WAS RAISED FOR THE STEP UP X-RAY TAKEN BY THE RADIOGRAPHER AT THE RADIOLOGY CLINIC. IN ADDITION, THE INCORRECT LEG RAISED X-RAY WAS MISSED DURING THE INITIAL QUALITY CHECK AND BY THE SUBSEQUENT OPERATIONS. ALTHOUGH MEASURED CORRECTLY THE X-RAY SHOULD NOT BE HAVE BEEN USED AT ALL. THE ERROR WAS SUBSEQUENTLY MISSED DURING FINAL CHECKS OF IMPLANTS AND REPORT SENDING FOR OPS INSIGHT. AS A RESULT, NO OPS INSIGHT SUMMARY REPORT WAS CREATED AND ONLY THE ONLINE PLANNING WAS VISIBLE. USING THE INCORRECT STEP UP X-RAY, THE ANTERIOR MOTION OF THE PROSTHETIC HEAD DURING THE EXTENSION ACTIVITY IS LONGER AND GOES CLOSER TO THE ANTERIOR RIM OF THE CUP. AS A RESULT THE DISTANCE BETWEEN THE PROSTHETIC HEAD TO THE ANTERIOR RIM OF THE CUP IS SMALLER FOR ALL ORIENTATIONS. ALTHOUGH INCORRECT, THE EFFECT ON THE ORIENTATION SELECTION IS A LARGER SAFETY BUFFER AS THE RESULTING ACCEPTABLE CUP ORIENTATIONS IS RESTRICTED TO A SMALLER SUBSET OF ACCEPTABLE ORIENTATIONS. CONCLUSION: THIS WAS AN OPERATOR ERROR AT BOTH THE RADIOLOGY AND MANUFACTURER END. HOWEVER, NO ADVERSE PATIENT CONSEQUENCES HAVE BEEN REPORTED FOR THIS CASE. 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

    IT WAS NOTICED AND REPORTED BY AN INTERNAL OPTIMIZED ORTHO EMPLOYEE THAT THE PATIENT HAD RAISED THE WRONG LEG DURING THE STEP-UP X-RAY. THESE X-RAYS ARE PART OF PRE-IMAGING WHICH OPTIMISED ORTHO USES TO PROCESS THE CASE. THE INCORRECT STEP-UP X-RAY WAS ALSO USED IN THE INSIGHT APPLICATION FOR PREOPERATIVE SURGICAL PLANNING . THE SURGERY WENT AHEAD WITH THE WRONG STEP-UP X-RAY. NO PATIENT CONSEQUENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    WE ARE CURRENTLY IN THE PROCESS OF INVESTIGATING THIS COMPLAINT. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS NOTICED AND REPORTED BY AN INTERNAL OPTIMIZED ORTHO EMPLOYEE THAT THE PATIENT HAD RAISED THE WRONG LEG DURING THE STEP-UP X-RAY. THESE X-RAYS ARE PART OF PRE-IMAGING WHICH OPTIMISED ORTHO USES TO PROCESS THE CASE. THE INCORRECT STEP-UP X-RAY WAS ALSO USED IN THE INSIGHT APPLICATION FOR PREOPERATIVE SURGICAL PLANNING . THE SURGERY WENT AHEAD WITH THE WRONG STEP-UP X-RAY. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571605 OPTIMIZED POSITIONING SYSTEM (OPS) INSIGHT OPS INSIGHT LZO OPTIMIZED ORTHO PTY LTD BAR_JT_22778

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR