BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9448601 · Received December 10, 2019

    Report

    Report Number
    3012916784-2019-00031
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    November 25, 2019
    Report Date
    January 17, 2020
    Manufacturer
    OPTIMIZED ORTHO PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    K152893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SURGEON REPORTED THAT THE DESIGN OF THE PATIENT SPECIFIC ACETABULAR GUIDE (K152893) WAS NOT STABLE IN THE PATIENT'S ACETABULUM. THE SURGEON ABANDONED THE USE OF THE ACETABULAR GUIDE AND PROCEEDED WITH STANDARD THA PROCEDURE, WITH NO ADDITIONAL RISK TO THE PATIENT AS A RESULT. IF THE PATIENT SPECIFIC ACETABULAR GUIDE IS UNSTABLE, IT CAN RESULT IN THE INACCURATE DELIVERY OF THE SURGEON'S CHOSEN TARGET ACETABULAR ORIENTATION. THIS ISSUE WAS CONFIRMED TO NOT RESULT IN AN ADVERSE EVENT AND/OR FURTHER INTERVENTION FOR THE PATIENT. IT WAS FOUND THAT DURING THE DESIGN OF THE ACETABULAR GUIDE THE SURGEON'S PREFERRED ARM DESIGN WAS NOT FOLLOWED. WHILE IT STATES IN OUR WORK INSTRUCTIONS THAT DEVIATIONS ARE PERMITTED IN ORDER TO MAINTAIN STABILITY OR USABILITY OF THE GUIDE DUE TO PATIENT SPECIFIC ANATOMY. AT THE TIME OF PROCESSING, THE SURGEONS PREFERENCES SPECIFIED THE ANTERIOR ARM AS "ON RIM" DESIGN AND THE POSTERIOR ARM AS "NARROW BELOW RIM" OR "IN ARM" DESIGN. THE OPS PRODUCTION ENGINEER DESIGNING THE GUIDE CHOSE TO USE A "NARROW BELOW RIM" DESIGN FOR THE ANTERIOR ARM AS AN APPROPRIATE LOCATION FOR AN "ON RIM" ARM COULD NOT BE PINPOINTED. THE ENGINEER INDICATED THAT AN "ON RIM" DESIGN WAS NOT SUITABLE FOR THIS PATIENT'S ANATOMY AND WOULD CAUSE A RISK OF INSTABILITY. IT WAS FOUND THAT THE SURGEON'S PREFERRED ARM DESIGN COULD NOT BE FOLLOWED WITHOUT COMPROMISING STABILITY, AND THE ARM DESIGN CHOSEN WAS INTENDED TO INCREASE STABILITY. THE CAUSE OF THE INSTABILITY EXPERIENCED COULD NOT BE DETERMINED. 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

    SURGEON REPORTED THAT THE DESIGN OF THE PATIENT SPECIFIC ACETABULAR GUIDE (K152893) WAS NOT STABLE IN THE PATIENT'S ACETABULUM. THE SURGEON ABANDONED THE USE OF THE ACETABULAR GUIDE AND PROCEEDED WITH STANDARD THA PROCEDURE, WITH NO ADDITIONAL RISK TO THE PATIENT AS A RESULT. IF THE PATIENT SPECIFIC ACETABULAR GUIDE IS UNSTABLE, IT CAN RESULT IN THE INACCURATE DELIVERY OF THE SURGEON'S CHOSEN TARGET ACETABULAR ORIENTATION. THIS ISSUE WAS CONFIRMED TO NOT RESULT IN AN ADVERSE EVENT AND/OR FURTHER INTERVENTION FOR THE PATIENT. IT WAS FOUND THAT DURING THE DESIGN OF THE ACETABULAR GUIDE THE SURGEON'S PREFERRED ARM DESIGN WAS NOT FOLLOWED. WHILE IT STATES IN OUR WORK INSTRUCTIONS THAT DEVIATIONS ARE PERMITTED IN ORDER TO MAINTAIN STABILITY OR USABILITY OF THE GUIDE DUE TO PATIENT SPECIFIC ANATOMY. AT THE TIME OF PROCESSING, THE SURGEONS PREFERENCES SPECIFIED THE ANTERIOR ARM AS "ON RIM" DESIGN AND THE POSTERIOR ARM AS "NARROW BELOW RIM" OR "IN ARM" DESIGN. THE OPS PRODUCTION ENGINEER DESIGNING THE GUIDE CHOSE TO USE A "NARROW BELOW RIM" DESIGN FOR THE ANTERIOR ARM AS AN APPROPRIATE LOCATION FOR AN "ON RIM" ARM COULD NOT BE PINPOINTED. THE ENGINEER INDICATED THAT AN "ON RIM" DESIGN WAS NOT SUITABLE FOR THIS PATIENT'S ANATOMY AND WOULD CAUSE A RISK OF INSTABILITY. IT WAS FOUND THAT THE SURGEON'S PREFERRED ARM DESIGN COULD NOT BE FOLLOWED WITHOUT COMPROMISING STABILITY, AND THE ARM DESIGN CHOSEN WAS INTENDED TO INCREASE STABILITY. THE CAUSE OF THE INSTABILITY EXPERIENCED COULD NOT BE DETERMINED. 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

    SURGEON REPORTED THAT THE DESIGN OF THE PATIENT SPECIFIC ACETABULAR GUIDE (K152893) WAS NOT STABLE IN THE PATIENT'S ACETABULUM. THE SURGEON ABANDONED THE USE OF THE ACETABULAR GUIDE AND PROCEEDED WITH STANDARD THA PROCEDURE, WITH NO ADDITIONAL RISK TO THE PATIENT AS A RESULT. IF THE PATIENT SPECIFIC ACETABULAR GUIDE IS UNSTABLE, IT CAN RESULT IN THE INACCURATE DELIVERY OF THE SURGEON'S CHOSEN TARGET ACETABULAR ORIENTATION. THIS ISSUE WAS CONFIRMED TO NOT RESULT IN AN ADVERSE EVENT AND/OR FURTHER INTERVENTION FOR THE PATIENT. 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

    SURGEON REPORTED THAT THE DESIGN OF THE PATIENT SPECIFIC ACETABULAR GUIDE (K152893) WAS NOT STABLE IN THE PATIENT'S ACETABULUM. THE SURGEON ABANDONED THE USE OF THE ACETABULAR GUIDE AND PROCEEDED WITH STANDARD THA PROCEDURE, WITH NO ADDITIONAL RISK TO THE PATIENT AS A RESULT. IF THE PATIENT SPECIFIC ACETABULAR GUIDE IS UNSTABLE, IT CAN RESULT IN THE INACCURATE DELIVERY OF THE SURGEON'S CHOSEN TARGET ACETABULAR ORIENTATION. THIS ISSUE WAS CONFIRMED TO NOT RESULT IN AN ADVERSE EVENT AND/OR FURTHER INTERVENTION FOR THE PATIENT. 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
    1243271 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD 1248-1500 WIS_DK_19307

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR