BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9625375 · Received January 24, 2020

    Report

    Report Number
    3012916784-2020-00050
    Event Type
    Injury
    Date Received
    January 24, 2020
    Date of Event
    January 2, 2020
    Report Date
    May 13, 2020
    Manufacturer
    OPTIMIZED ORTHO PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    K152893
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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, PRE-OPERATIVE IMAGING & OPS ACETABULAR & FEMORAL GUIDES. RESULTS: NO NON-CONFORMANCE WERE RAISED DURING THE DESIGN OF THE ACETABULAR & FEMORAL PATIENT SPECIFIC GUIDE. THE DESIGN OF THE PATIENT SPECIC GUIDES IS DETERMINED TO BE UNRELATED TO THE FAILURE MODE OF DISLOCATION. 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 OPTRSK-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. IT IS LIKELY THAT THIS REVISION OCCURRED AS A RESULT OF PATIENT CONDITIONS.

    Description of Event or Problem · 0

    PATIENT RECEIVED PRIMARY THA PROCEDURE ON (B)(6) 2019 AND WAS REVISED ON (B)(6) 2020. PATIENT RECEIVED THE USE OF THE PATIENT SPECIFIC ACETABULAR GUIDE (K152893), FEMORAL GUIDE (K181061) AND FHA REPORT IN THE PRIMARY SURGERY. POST-OPERATIVE IMAGING HAS BEEN REQUESTED FROM THE REPORTER OF THIS ISSUE TO COMPARE THE PLANNED AND ACHIEVED POSITIONING OF THE POSITIONING.

    Additional Manufacturer Narrative · 1

    PATIENT RECEIVED PRIMARY THA PROCEDURE (B)(6) 2019 AND WAS REVISED ON (B)(6) 2020. PATIENT RECEIVED THE USE OF THE PATIENT SPECIFIC ACETABULAR GUIDE (K152893), FEMORAL GUIDE (K181061) AND FHA REPORT IN THE PRIMARY SURGERY. POST-OPERATIVE IMAGING HAS BEEN REQUESTED FROM THE REPORTER OF THIS ISSUE TO COMPARE THE PLANNED AND ACHIEVED POSITIONING OF THE POSITIONING.

    Description of Event or Problem · 1

    PATIENT RECEIVED PRIMARY THA PROCEDURE (B)(6) 2019 AND WAS REVISED ON (B)(6) 2020. PATIENT RECEIVED THE USE OF THE PATIENT SPECIFIC ACETABULAR GUIDE (K152893), FEMORAL GUIDE (K181061) AND FHA REPORT IN THE PRIMARY SURGERY. POST-OPERATIVE IMAGING HAS BEEN REQUESTED FROM THE REPORTER OF THIS ISSUE TO COMPARE THE PLANNED AND ACHIEVED POSITIONING OF THE POSITIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88573 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD 1248-1500 WIN_SB_19883

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention