BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9572436 · Received January 9, 2020

    Report

    Report Number
    3012916784-2020-00041
    Event Type
    Malfunction
    Date Received
    January 9, 2020
    Date of Event
    December 10, 2019
    Report Date
    January 23, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT SPECIFIC ACETABULAR GUIDE (K152893) WAS REPORTED TO BE UNSTABLE IN THE PATIENT'S ACETABULUM. THIS RISK IS DETERMINED TO POTENTIALLY LEAD TO AN ADVERSE EVENT FOR THE PATIENT, AS THIS MAY LEAD TO PATIENT SPECIFIC INSTRUMENT MAY DELIVER A SUB-OPTIMAL ACETABULAR ORIENTATION, RESULTING IN HIP PAIN OR GAIT PROBLEMS. IN THIS CASE, NO ADVERSE EVENT WAS REPORTED TO RESULT FROM THIS ISSUE. THE SURGEON PROCEEDED WITH THE USE OF THE ACETABULAR GUIDE DESPITE THE REPORTED ISSUE. POST-OPERATIVE IMAGING HAS BEEN REQUESTED FROM THE REPORTER IN ORDER TO DETERMINE THE ACHIEVED CUP POSITIONING. A ROOT CAUSE INVESTIGATION HAS BEEN CONDUCTED INTO THIS EVENT. IT WAS FOUND THAT THE DESIGN OF THE ACETABULAR GUIDE WAS APPROPRIATE TO ACHIEVE STABILITY IN THE PATIENT'S ACETABULUM. ALL WORK INSTRUCTIONS WERE ADHERED TO AND THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATION. NO POST-OPERATIVE IMAGING WAS PROVIDED AND NO ANALYSIS COULD BE CONDUCTED TO COMPARE PLANNED AND ACHIEVED CUP POSITIONING. NO ADVERSE EVENT WAS REPORTED FOR THIS PATIENT. NO REASON FOR THE REPORTED INSTABILITY COULD BE IDENTIFIED. 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 PATIENT SPECIFIC ACETABULAR GUIDE (K152893) WAS REPORTED TO BE UNSTABLE IN THE PATIENT'S ACETABULUM. THIS RISK IS DETERMINED TO POTENTIALLY LEAD TO AN ADVERSE EVENT FOR THE PATIENT, AS THIS MAY LEAD TO PATIENT SPECIFIC INSTRUMENT MAY DELIVER A SUB-OPTIMAL ACETABULAR ORIENTATION, RESULTING IN HIP PAIN OR GAIT PROBLEMS. IN THIS CASE, NO ADVERSE EVENT WAS REPORTED TO RESULT FROM THIS ISSUE. THE SURGEON PROCEEDED WITH THE USE OF THE ACETABULAR GUIDE DESPITE THE REPORTED ISSUE. POST-OPERATIVE IMAGING HAS BEEN REQUESTED FROM THE REPORTER IN ORDER TO DETERMINE THE ACHIEVED CUP POSITIONING. A ROOT CAUSE INVESTIGATION HAS BEEN CONDUCTED INTO THIS EVENT. IT WAS FOUND THAT THE DESIGN OF THE ACETABULAR GUIDE WAS APPROPRIATE TO ACHIEVE STABILITY IN THE PATIENT'S ACETABULUM. ALL WORK INSTRUCTIONS WERE ADHERED TO AND THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATION. NO POST-OPERATIVE IMAGING WAS PROVIDED AND NO ANALYSIS COULD BE CONDUCTED TO COMPARE PLANNED AND ACHIEVED CUP POSITIONING. NO ADVERSE EVENT WAS REPORTED FOR THIS PATIENT. NO REASON FOR THE REPORTED INSTABILITY COULD BE IDENTIFIED. 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 PATIENT SPECIFIC ACETABULAR GUIDE (K152893) WAS REPORTED TO BE UNSTABLE IN THE PATIENT'S ACETABULUM. THIS RISK IS DETERMINED TO POTENTIALLY LEAD TO AN ADVERSE EVENT FOR THE PATIENT, AS THIS MAY LEAD TO PATIENT SPECIFIC INSTRUMENT MAY DELIVER A SUB-OPTIMAL ACETABULAR ORIENTATION, RESULTING IN HIP PAIN OR GAIT PROBLEMS. IN THIS CASE, NO ADVERSE EVENT WAS REPORTED TO RESULT FROM THIS ISSUE. THE SURGEON PROCEEDED WITH THE USE OF THE ACETABULAR GUIDE DESPITE THE REPORTED ISSUE. POST-OPERATIVE IMAGING HAS BEEN REQUESTED FROM THE REPORTER IN ORDER TO DETERMINE THE ACHIEVED CUP POSITIONING. 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 PATIENT SPECIFIC ACETABULAR GUIDE (K152893) WAS REPORTED TO BE UNSTABLE IN THE PATIENT'S ACETABULUM. THIS RISK IS DETERMINED TO POTENTIALLY LEAD TO AN ADVERSE EVENT FOR THE PATIENT, AS THIS MAY LEAD TO PATIENT SPECIFIC INSTRUMENT MAY DELIVER A SUB-OPTIMAL ACETABULAR ORIENTATION, RESULTING IN HIP PAIN OR GAIT PROBLEMS. IN THIS CASE, NO ADVERSE EVENT WAS REPORTED TO RESULT FROM THIS ISSUE. THE SURGEON PROCEEDED WITH THE USE OF THE ACETABULAR GUIDE DESPITE THE REPORTED ISSUE. POST-OPERATIVE IMAGING HAS BEEN REQUESTED FROM THE REPORTER IN ORDER TO DETERMINE THE ACHIEVED CUP POSITIONING. 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
    36208 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD 1248-0500 KEM_JH_19990

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR