BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9845516 · Received March 17, 2020

    Report

    Report Number
    3012916784-2020-00055
    Event Type
    Injury
    Date Received
    March 17, 2020
    Date of Event
    February 24, 2020
    Report Date
    April 29, 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 LES 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 SPECIC GUIDES. THE DESIGN OF THE PATIENT SPECIC GUIDES IS DETERMINED TO BE UNRELATED TO THE FAILURE MODE OF INFECTION. THE INTENDED MOIST HEAT STERILISATION METHOD FOR STERILIZING THE OPS PATIENT SPECIC 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 DECIENT. 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: THIS FAILURE MODE IS NOT ASSOCIATED WITH THE USE OF OPS TECHNOLOGY IN THE PRIMARY SURGERY AND THERE IS NO EVIDENCE TO SUGGEST THAT THE USE OF OPS TECHNOLOGY IN THE PRIMARY SURGERY CONTRIBUTED TO THIS REVISION EVENT. THE SURGEON'S REPRESENTATIVE CONRMED THIS CONCLUSION IN FOLLOW UP QUESTIONING ABOUT THE COMPLAINT; "ALTHOUGH OPS WAS USED IN THE PRIMARY TOTAL HIP IT WAS NOT THE CAUSE OF, NOR WAS IT RELATED TO, THE REVISION." 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

    IT WAS REPORTED BY A CORIN REPRESENTATIVE IN AUSTRALIA THAT THERE WAS A REVISION DUE TO INFECTION IN THE HIP A FEW MONTHS AFTER THE PRIMARY SURGERY. THE PATIENT HAD THE TRINITY CUP SYSTEM IMPLANTED. DURING PRIMARY PROCEDURE, OPS TECHNOLOGY (OPS PLAN WITH DHA & ACETABULAR GUIDE) WERE EMPLOYED AS ASSISTIVE TECHNOLOGY.

    Additional Manufacturer Narrative · 1

    WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION AND COMPLETE THE ROOT CAUSE INVESTIGATION. THE FINAL REPORT WILL BE SENT UPON CLOSURE OF ROOT CAUSE INVESTIGATION. 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

    IT WAS REPORTED BY A CORIN REPRESENTATIVE IN (B)(6) THAT THERE WAS A REVISION DUE TO INFECTION IN THE HIP A FEW MONTHS AFTER THE PRIMARY SURGERY. THE PATIENT HAD THE TRINITY CUP SYSTEM IMPLANTED. DURING PRIMARY PROCEDURE, OPS TECHNOLOGY (OPS PLAN WITH DHA & ACETABULAR GUIDE) WERE EMPLOYED AS ASSISTIVE TECHNOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308692 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD 1248-0500 VAN_MO_18566

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention