BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9579571 · Received January 12, 2020

    Report

    Report Number
    3012916784-2020-00042
    Event Type
    Malfunction
    Date Received
    January 12, 2020
    Date of Event
    December 16, 2019
    Report Date
    February 12, 2020
    Manufacturer
    OPTIMIZED ORTHO PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    K181061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT SPECIFIC FEMORAL GUIDE (K181061) WAS REPORTED TO INDICATE AN OSTEOTOMY LEVEL THAT RESULTED IN THE LT DISTANCE BEING 10MM, WHEN A LT DISTANCE OF 5MM HAD BEEN PLANNED PRE-OPERATIVELY. THE RISK OF SUB-OPTIMAL OSTEOTOMY LEVEL IS CONSIDERED TO BE A RISK OF SERIOUS INJURY OR ADVERSE EVENT FOR THE PATIENT. POST-OPERATIVE IMAGING HAS BEEN REQUESTED FROM THE REPORTER TO CONFIRM THE EFFECT OF THIS ISSUE ON THE PATIENT. NO ADVERSE EVENT OR REINTERVENTION HAS BEEN REPORTED FOR THIS PATIENT. A ROOT CAUSE INVESTIGATION HAS NOW BEEN CONDUCTED INTO THIS EVENT. THE FEMORAL GUIDE WAS DESIGNED TO THE CORRECT PRODUCTION PROCESS, ADHERING TO THE RELEVANT WORK INSTRUCTION. THE CASE WAS REPROCESSED CORRECTLY AND THE RIGHT DISTANCE FROM THE LOWER TROCHANTER WAS CALCULATED. THE FEMORAL GUIDE WAS THEN DESIGNED BASED ON THIS RESECTION AND WAS SENT TO THE EXTERNAL SUPPLIER MATERIALISE TO BE PRINTED. MATERIALISE HAS ALSO CONFIRMED THAT THE CORRECT STEM FEMORAL GUIDE WAS PRINTED AND SENT. AS IT HAS BEEN DETERMINED THAT THE PRODUCTS INVOLVED IN THIS COMPLAINT ACCURATELY AND CORRECTLY FOLLOWED THE STEPS LAID OUT IN THE RELEVANT WKIS, IT IS LIKELY THAT THE ROOT CAUSE OF THIS OCCURRED OUT OF THE CONTROL OF INTERNAL PROCESS, AND AS SUCH NO ROOT CAUSE COULD BE IDENTIFIED. 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 FEMORAL GUIDE (K181061) WAS REPORTED TO INDICATE AN OSTEOTOMY LEVEL THAT RESULTED IN THE LT DISTANCE BEING 10MM, WHEN A LT DISTANCE OF 5MM HAD BEEN PLANNED PRE-OPERATIVELY. THE RISK OF SUB-OPTIMAL OSTEOTOMY LEVEL IS CONSIDERED TO BE A RISK OF SERIOUS INJURY OR ADVERSE EVENT FOR THE PATIENT. POST-OPERATIVE IMAGING HAS BEEN REQUESTED FROM THE REPORTER TO CONFIRM THE EFFECT OF THIS ISSUE ON THE PATIENT. NO ADVERSE EVENT OR REINTERVENTION HAS BEEN REPORTED FOR THIS PATIENT. A ROOT CAUSE INVESTIGATION HAS NOW BEEN CONDUCTED INTO THIS EVENT. THE FEMORAL GUIDE WAS DESIGNED TO THE CORRECT PRODUCTION PROCESS, ADHERING TO THE RELEVANT WORK INSTRUCTION. THE CASE WAS REPROCESSED CORRECTLY AND THE RIGHT DISTANCE FROM THE LOWER TROCHANTER WAS CALCULATED. THE FEMORAL GUIDE WAS THEN DESIGNED BASED ON THIS RESECTION AND WAS SENT TO THE EXTERNAL SUPPLIER MATERIALISE TO BE PRINTED. MATERIALISE HAS ALSO CONFIRMED THAT THE CORRECT STEM FEMORAL GUIDE WAS PRINTED AND SENT. AS IT HAS BEEN DETERMINED THAT THE PRODUCTS INVOLVED IN THIS COMPLAINT ACCURATELY AND CORRECTLY FOLLOWED THE STEPS LAID OUT IN THE RELEVANT WKIS, IT IS LIKELY THAT THE ROOT CAUSE OF THIS OCCURRED OUT OF THE CONTROL OF INTERNAL PROCESS, AND AS SUCH NO ROOT CAUSE COULD BE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THE PATIENT SPECIFIC FEMORAL GUIDE (K181061) WAS REPORTED TO INDICATE AN OSTEOTOMY LEVEL THAT RESULTED IN THE LT DISTANCE BEING 10MM, WHEN A LT DISTANCE OF 5MM HAD BEEN PLANNED PRE-OPERATIVELY. THE RISK OF SUB-OPTIMAL OSTEOTOMY LEVEL IS CONSIDERED TO BE A RISK OF SERIOUS INJURY OR ADVERSE EVENT FOR THE PATIENT. POST-OPERATIVE IMAGING HAS BEEN REQUESTED FROM THE REPORTER TO CONFIRM THE EFFECT OF THIS ISSUE ON THE PATIENT. NO ADVERSE EVENT OR REINTERVENTION HAS BEEN REPORTED FOR THIS PATIENT.

    Description of Event or Problem · 1

    THE PATIENT SPECIFIC FEMORAL GUIDE (K181061) WAS REPORTED TO INDICATE AN OSTEOTOMY LEVEL THAT RESULTED IN THE LT DISTANCE BEING 10MM, WHEN A LT DISTANCE OF 5MM HAD BEEN PLANNED PRE-OPERATIVELY. THE RISK OF SUB-OPTIMAL OSTEOTOMY LEVEL IS CONSIDERED TO BE A RISK OF SERIOUS INJURY OR ADVERSE EVENT FOR THE PATIENT. POST-OPERATIVE IMAGING HAS BEEN REQUESTED FROM THE REPORTER TO CONFIRM THE EFFECT OF THIS ISSUE ON THE PATIENT. NO ADVERSE EVENT OR REINTERVENTION HAS BEEN REPORTED FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42688 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD 1248-1100 BAY_WR_19293

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR