BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9703376 · Received February 12, 2020

    Report

    Report Number
    3012916784-2020-00054
    Event Type
    Malfunction
    Date Received
    February 12, 2020
    Date of Event
    February 6, 2020
    Report Date
    February 13, 2020
    Manufacturer
    OPTIMIZED ORTHO PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    K183038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    METHOD: OPS PLAN (OLD AND REVISED), PRE-OPERATIVE IMAGING AND THE DEVICE HISTORY RECORD WERE INVESTIGATED. RESULTS: UPON COMPARING THE OLD OPS PLAN WITH THE INCORRECT PATIENT DATA WITH THE REVISED OPS PLAN WHICH WAS REPRODUCED USING THE CORRECT PATIENT DATA. IT CAN BE SEEN THAT THE PRE-OPERATIVE AP XRAYS FOR BOTH REPORTS WERE CORRECT, AS WERE THE STEM OSTEOTOMY PICTURE AND STEM CORONAL PICTURE. IT IS ONLY THE SIMULATED PATIENT POST-OPERATIVE "REDUCED VIEW" WHICH WAS PRODUCED WITH THE INCORRECT PATIENTS IMAGING. IT IS CLEAR THAT THIS ISSUE RELATES SOLELY TO OPERATOR ERROR, BOTH OF THE OP45 OPERATOR WHO PRODUCED THE REPORTS, AND THE OP50 OPERATOR WHO REVIEWED THE REPORTS AND SENT THEM EXTERNALLY. CONCLUSION: THE ISSUE OCCURED AS A RESULT OF A OPERATOR ERROR. NO PATIENT HARM OCCURRED AS A RESULT OF THIS ISSUE. 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

    THE OPS PLAN REPORT (K183038) CONTAINED AN IMAGE (REDUCED VIEW IMAGE) FROM A DIFFERENT PATIENT COMPARED TO THE REST OF THE PRE-OPERATIVE PLANNING. IF THIS ISSUE WAS NOT DETECTED PRIOR TO USE, THE SURGEON MAY MAKE CLINICAL DECISIONS BASED ON INCORRECT INFORMATION, WHICH WOULD POTENTIALLY LEAD TO PATIENT INJURY, PAIN OR GAIT PROBLEMS. THIS ISSUE WAS DETECTED PRIOR TO THE POINT OF USE OF THE DEVICE AND WAS CORRECTED. NO EFFECT ON THE PATIENT WAS REPORTED. 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

    THE OPS PLAN REPORT (K183038) CONTAINED AN IMAGE (REDUCED VIEW IMAGE) FROM A DIFFERENT PATIENT COMPARED TO THE REST OF THE PRE-OPERATIVE PLANNING. IF THIS ISSUE WAS NOT DETECTED PRIOR TO USE, THE SURGEON MAY MAKE CLINICAL DECISIONS BASED ON INCORRECT INFORMATION, WHICH WOULD POTENTIALLY LEAD TO PATIENT INJURY, PAIN OR GAIT PROBLEMS. THIS ISSUE WAS DETECTED PRIOR TO THE POINT OF USE OF THE DEVICE AND WAS CORRECTED. NO EFFECT ON THE PATIENT WAS REPORTED. 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

    THE OPS PLAN REPORT (K183038) CONTAINED AN IMAGE (REDUCED VIEW IMAGE) FROM A DIFFERENT PATIENT COMPARED TO THE REST OF THE PRE-OPERATIVE PLANNING. IF THIS ISSUE WAS NOT DETECTED PRIOR TO USE, THE SURGEON MAY MAKE CLINICAL DECISIONS BASED ON INCORRECT INFORMATION, WHICH WOULD POTENTIALLY LEAD TO PATIENT INJURY, PAIN OR GAIT PROBLEMS. THIS ISSUE WAS DETECTED PRIOR TO THE POINT OF USE OF THE DEVICE AND WAS CORRECTED. NO EFFECT ON THE PATIENT WAS REPORTED. 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
    167145 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD N/A LAN_GS_21326

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR