BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9583840 · Received January 13, 2020

    Report

    Report Number
    3012916784-2020-00043
    Event Type
    Injury
    Date Received
    January 13, 2020
    Date of Event
    December 13, 2019
    Report Date
    January 28, 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

    PATIENT WAS REVISED AFTER ALMOST 3 YEARS DUE TO INFECTION. PATIENT RECEIVED PRIMARY TOTAL HIP ARTHROPLASTY PROCEDURE ON 21 MARCH 2017, WHERE THE USE OF THE PATIENT SPECIFIC ACETABULAR (K152893) AND FEMORAL GUIDES (K181061) WAS EMPLOYED. THE PATIENT EXPERIENCED LYSIS AROUND THE CALCAR AS A RESULT OF INFECTION AND WAS REVISED ON (B)(6) 2019, WHERE THE FEMORAL STEM, FEMORAL HEAD, AND ACETABULAR LINER WERE REVISED. OPTIMIZED ORTHO DOES NOT STERILISE THE DEVICES PRIOR TO DISPATCH, INSTRUCTIONS FOR VALIDATED STERILISATION TECHNIQUE ARE PROVIDED TO THE HOSPITAL WHERE THE SURGERY TAKES PLACE. A ROOT CAUSE INVESTIGATION HAS NOW BEEN CONDUCTED INTO THIS EVENT. TESTING PERFORMED ON THE STERILISATION OF THE PATIENT SPECIFIC INSTRUMENTS DEMONSTRATED THAT A SAL OF 10-6 WAS ACHIEVED AS PER (B)(4), AND THAT NO VISIBLE MOISTURE WAS PRESENT AFTER FULL CYCLE EXPOSURE AND DRY TIME (OPT-REP-93 OPS PATIENT SPECIFIC INSTRUMENT STERILISATION VALIDATION TESTING REPORT). THIS TESTING VALIDATED THE INTENDED MOIST HEAT STERILIZATION FOR STERILISING THE OPS PATIENT SPECIFIC INSTRUMENTS. 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 A SAL 10-6. 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

    PATIENT WAS REVISED AFTER ALMOST 3 YEARS DUE TO INFECTION. PATIENT RECEIVED PRIMARY TOTAL HIP ARTHROPLASTY PROCEDURE ON (B)(6) 2017, WHERE THE USE OF THE PATIENT SPECIFIC ACETABULAR (K152893) AND FEMORAL GUIDES (K181061) WAS EMPLOYED. THE PATIENT EXPERIENCED LYSIS AROUND THE CALCAR AS A RESULT OF INFECTION AND WAS REVISED ON (B)(6) 2019, WHERE THE FEMORAL STEM, FEMORAL HEAD, AND ACETABULAR LINER WERE REVISED. OPTIMIZED ORTHO DOES NOT STERILISE THE DEVICES PRIOR TO DISPATCH, INSTRUCTIONS FOR VALIDATED STERILISATION TECHNIQUE ARE PROVIDED TO THE HOSPITAL WHERE THE SURGERY TAKES PLACE. A ROOT CAUSE INVESTIGATION HAS NOW BEEN CONDUCTED INTO THIS EVENT. TESTING PERFORMED ON THE STERILISATION OF THE PATIENT SPECIFIC INSTRUMENTS DEMONSTRATED THAT A SAL OF 10-6 WAS ACHIEVED AS PER ISO17665-1, AND THAT NO VISIBLE MOISTURE WAS PRESENT AFTER FULL CYCLE EXPOSURE AND DRY TIME (OPT-REP-93 OPS PATIENT SPECIFIC INSTRUMENT STERILISATION VALIDATION TESTING REPORT). THIS TESTING VALIDATED THE INTENDED MOIST HEAT STERILIZATION FOR STERILISING THE OPS PATIENT SPECIFIC INSTRUMENTS. 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 A SAL 10-6. 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

    PATIENT WAS REVISED AFTER ALMOST 3 YEARS DUE TO INFECTION. PATIENT RECEIVED PRIMARY TOTAL HIP ARTHROPLASTY PROCEDURE ON (B)(6) 2017, WHERE THE USE OF THE PATIENT SPECIFIC ACETABULAR (K152893) AND FEMORAL GUIDES (K181061) WAS EMPLOYED. THE PATIENT EXPERIENCED LYSIS AROUND THE CALCAR AS A RESULT OF INFECTION AND WAS REVISED ON (B)(6) 2019, WHERE THE FEMORAL STEM, FEMORAL HEAD, AND ACETABULAR LINER WERE REVISED. 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 WAS REVISED AFTER ALMOST 3 YEARS DUE TO INFECTION. PATIENT RECEIVED PRIMARY TOTAL HIP ARTHROPLASTY PROCEDURE ON (B)(6) 2017, WHERE THE USE OF THE PATIENT SPECIFIC ACETABULAR (K152893) AND FEMORAL GUIDES (K181061) WAS EMPLOYED. THE PATIENT EXPERIENCED LYSIS AROUND THE CALCAR AS A RESULT OF INFECTION AND WAS REVISED ON (B)(6) 2019, WHERE THE FEMORAL STEM, FEMORAL HEAD, AND ACETABULAR LINER WERE REVISED. OPTIMIZED ORTHO DOES NOT STERILISE THE DEVICES PRIOR TO DISPATCH, INSTRUCTIONS FOR VALIDATED STERILISATION TECHNIQUE ARE PROVIDED TO THE HOSPITAL WHERE THE SURGERY TAKES PLACE. 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
    45196 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD 1248-1500 RIC_JH_6853H

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention