BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9455616 · Received December 11, 2019

    Report

    Report Number
    3012916784-2019-00034
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Date of Event
    November 27, 2019
    Report Date
    January 17, 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

    THE OPS PLAN (K183038) REPORT PROVIDED TO THE SURGEON FEATURED A REDUCED VIEW IMAGE IN WHICH THE FEMUR WAS NOT REDUCED. THIS ISSUE WAS DETECTED BY THE SURGEON WHEN THE PROSTHETIC HEAD WAS NOT CENTRED WITH THE CUP IN THE OPS PLAN, PRIOR TO THE POINT OF USE IN THE SURGERY. IF THE REDUCED VIEW IMAGE FEATURED AN INCORRECT REDUCTION, THE SURGEON MAY MAKE CLINICAL DECISIONS BASED ON THIS INCORRECT IMAGE. THIS ISSUE WAS DETECTED PRIOR TO THE POINT OF USE IN THE SURGERY AND WAS CORRECTED AND RESENT TO THE SURGEON. A ROOT CAUSE INVESTIGATION WAS CONDUCTED INTO THIS EVENT. DURING THE PRE-OPERATIVE PLANNING OF IMPLANT POSITIONING, AN ALTERNATE FILE WAS INCORRECTLY ARCHIVED AND ACCIDENTALLY INCLUDED IN THE OPS PLAN REPORT. AS A RESULT OF THIS INVESTIGATION, THE ROOT CAUSE OF THIS ISSUE WAS DETERMINED TO BE OPERATOR ERROR. 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 (K183038) REPORT PROVIDED TO THE SURGEON FEATURED A REDUCED VIEW IMAGE IN WHICH THE FEMUR WAS NOT REDUCED. THIS ISSUE WAS DETECTED BY THE SURGEON WHEN THE PROSTHETIC HEAD WAS NOT CENTRED WITH THE CUP IN THE OPS PLAN, PRIOR TO THE POINT OF USE IN THE SURGERY. IF THE REDUCED VIEW IMAGE FEATURED AN INCORRECT REDUCTION, THE SURGEON MAY MAKE CLINICAL DECISIONS BASED ON THIS INCORRECT IMAGE. THIS ISSUE WAS DETECTED PRIOR TO THE POINT OF USE IN THE SURGERY AND WAS CORRECTED AND RESENT TO THE SURGEON. A ROOT CAUSE INVESTIGATION WAS CONDUCTED INTO THIS EVENT. DURING THE PRE-OPERATIVE PLANNING OF IMPLANT POSITIONING, AN ALTERNATE FILE WAS INCORRECTLY ARCHIVED AND ACCIDENTALLY INCLUDED IN THE OPS PLAN REPORT. AS A RESULT OF THIS INVESTIGATION, THE ROOT CAUSE OF THIS ISSUE WAS DETERMINED TO BE OPERATOR ERROR. 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 (K183038) REPORT PROVIDED TO THE SURGEON FEATURED A REDUCED VIEW IMAGE IN WHICH THE FEMUR WAS NOT REDUCED. THIS ISSUE WAS DETECTED BY THE SURGEON WHEN THE PROSTHETIC HEAD WAS NOT CENTRED WITH THE CUP IN THE OPS PLAN, PRIOR TO THE POINT OF USE IN THE SURGERY. IF THE REDUCED VIEW IMAGE FEATURED AN INCORRECT REDUCTION, THE SURGEON MAY MAKE CLINICAL DECISIONS BASED ON THIS INCORRECT IMAGE. THIS ISSUE WAS DETECTED PRIOR TO THE POINT OF USE IN THE SURGERY AND WAS CORRECTED AND RESENT TO THE SURGEON. 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

    THE OPS PLAN (K183038) REPORT PROVIDED TO THE SURGEON FEATURED A REDUCED VIEW IMAGE IN WHICH THE FEMUR WAS NOT REDUCED. THIS ISSUE WAS DETECTED BY THE SURGEON WHEN THE PROSTHETIC HEAD WAS NOT CENTRED WITH THE CUP IN THE OPS PLAN, PRIOR TO THE POINT OF USE IN THE SURGERY. IF THE REDUCED VIEW IMAGE FEATURED AN INCORRECT REDUCTION, THE SURGEON MAY MAKE CLINICAL DECISIONS BASED ON THIS INCORRECT IMAGE. THIS ISSUE WAS DETECTED PRIOR TO THE POINT OF USE IN THE SURGERY AND WAS CORRECTED AND RESENT TO THE SURGEON. 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
    1250261 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD RED_EO_20110

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR