BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9679746 · Received February 6, 2020

    Report

    Report Number
    3012916784-2020-00053
    Event Type
    Injury
    Date Received
    February 6, 2020
    Date of Event
    January 28, 2020
    Report Date
    June 24, 2020
    Manufacturer
    OPTIMIZED ORTHO PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    K152893
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    METHOD: NO COMPLAINT DEVICES WERE RETURNED TO OPTIMIZED ORTHO BY THE CUSTOMER. THUS, THE DEVICE HISTORY FILES WERE INVESTIGATED WHICH INCLUDED REVIEWING THE OPS PLAN, OPS ACETABULAR GUIDE & OPS FEMORAL GUIDE. RESULTS: NO NON-CONFORMANCE WERE RAISED DURING THE DESIGN OF THE ACETABULAR AND FEMORAL PATIENT SPECIFIC GUIDES. THE DESIGN OF THE PATIENT SPECIFIC GUIDES IS DETERMINED TO BE UNRELATED TO THE FAILURE MODE OF LINER DISENGAGING WITH THE CUP. THE INTENDED MOIST HEAT STERILISATION METHOD FOR STERILIZING THE OPS PATIENT SPECIFIC INSTRUMENTS HAS BEEN VALIDATED TO ACHIEVE A SAL 10-6 AS PER ISO17665-1. THERE WAS NO EVIDENCE TO SUGGEST THAT THE OPS TECHNOLOGY PROVIDED TO THE PRIMARY SURGERY MALFUNCTIONED OR WAS DEFICIENT. AS PER OPT-RSK-16 V111, THE CLEANING AND STERILISATION PARAMETERS HAVE BEEN VALIDATED BY OPTIMIZED ORTHO AND DEEMED ADEQUATE TO ACHIEVE SAL 10-6. THIS FAILURE MODE IS NOT ASSOCIATED WITH THE USE OF OPS TECHNOLOGY IN THE PRIMARY SURGERY. CONCLUSION: THERE IS NO EVIDENCE TO SUGGEST THAT THE OPS TECHNOLOGY PROVIDED TO THE PRIMARY SURGERY WAS NOT MANUFACTURED TO SPECIFICATION. NO NON-CONFORMANCE WERE RAISED DURING THE PROCESSING OF THIS CASE. THERE IS NO EVIDENCE TO SUGGEST THAT THE USE OF OPS TECHNOLOGY IN THE PRIMARY SURGERY CONTRIBUTED TO THIS REVISION EVENT. 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

    PATIENT UNDERWENT PRIMARY PROCEDURE FOR THA ON (B)(6) 2018. PATIENT HAS RECENTLY COMPLAINED OF DISCOMFORT. X RAYS SHOWED EVIDENCE THAT THE LINER WAS DISENGAGING WITH THE CUP. THEREFORE, PATIENT UNDERWENT REVISION PROCEDURE ON (B)(6) 2020. DURING REVISION PROCEDURE, THE SURGEON REPRESENTATIVE FOUND THAT THE PATIENT EXPERIENCED INFECTION FEW MONTHS AFTER PRIMARY PROCEDURE AND WAS ALREADY REVISED ON (B)(6) 2018. SUMMARY: PRIMARY THA PROCDURE: (B)(6) 2018. REVISION PROCDURE FOR INFECTION: (B)(6) 2018. REVISION PROCEDURE FOR LINER LOOSENING : (B)(6) 2020. DURING PRIMARY PROCEDURE , OPS TECHNOLOGY (OPS AND OPS FEMORAL ) WERE EMPLOYED AS ASSISTIVE TECHNOLOGY. THIS EVENT OCCURRED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    PATIENT UNDERWENT PRIMARY PROCEDURE FOR THA ON (B)(6) 2018. PATIENT HAS RECENTLY COMPLAINED OF DISCOMFORT . X RAYS SHOWED EVIDENCE THAT THE LINER WAS DISENGAGING WITH THE CUP. THEREFORE, PATIENT UNDERWENT REVISION PROCEDURE ON THE (B)(6) 2020. DURING REVISION PROCEDURE, THE SURGEON REPRESENTATIVE FOUND THAT THE PATIENT EXPERIENCED INFECTION FEW MONTHS AFTER PRIMARY PROCEDURE AND WAS ALREADY REVISED ON (B)(6) 2018. SUMMARY: PRIMARY THA PROCEDURE: (B)(6) 2018. REVISION PROCEDURE FOR INFECTION: (B)(6) 2018. REVISION PROCEDURE FOR LINER LOOSENING : (B)(6) 2020. DURING PRIMARY PROCEDURE , OPS TECHNOLOGY (OPS AND OPS FEMORAL ) WERE EMPLOYED AS ASSISTIVE TECHNOLOGY. 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

    PATIENT UNDERWENT PRIMARY PROCEDURE FOR THA ON (B)(6) 2018. PATIENT HAS RECENTLY COMPLAINED OF DISCOMFORT . X RAYS SHOWED EVIDENCE THAT THE LINER WAS DISENGAGING WITH THE CUP. THEREFORE, PATIENT UNDERWENT REVISION PROCEDURE ON THE (B)(6) 2020. DURING REVISION PROCEDURE, THE SURGEON REPRESENTATIVE FOUND THAT THE PATIENT EXPERIENCED INFECTION FEW MONTHS AFTER PRIMARY PROCEDURE AND WAS ALREADY REVISED ON (B)(6) 2018. SUMMARY: PRIMARY THA PROCEDURE: (B)(6) 2018. REVISION PROCEDURE FOR INFECTION: (B)(6) 2018. REVISION PROCEDURE FOR LINER LOOSENING : (B)(6) 2020. DURING PRIMARY PROCEDURE , OPS TECHNOLOGY (OPS AND OPS FEMORAL ) WERE EMPLOYED AS ASSISTIVE TECHNOLOGY. THIS EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139445 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD 1248_0500 SCH_SU_12827

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention