BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMIZED POSITIONING SYSTEM

    MDR report key: 11736000 · Received April 28, 2021

    Report

    Report Number
    3012916784-2021-00089
    Event Type
    Injury
    Date Received
    April 28, 2021
    Date of Event
    February 16, 2021
    Report Date
    April 28, 2021
    Manufacturer
    OPTIMIZED ORTHO PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    K181061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OPTIMISED ORTHO INVESTIGATION: NO COMPLAINT DEVICES WERE RETURNED TO OPTIMIZED ORTHO BY THE CUSTOMER. THUS, THE DEVICE PROCESSING FILES WERE INVESTIGATED WHICH INCLUDED REVIEWING OPS INSIGHT, THE ACETABULAR GUIDE, AND THE FEMORAL GUIDE. THE DESIGN OF PATIENT SPECIFIC GUIDES HAVE BEEN DETERMINED TO BE UNRELATED TO THE FAILURE MODE OF INFECTION. THE INTENDED MOIST HEAT STERILISATION METHOD FOR STERILISING THE OPS PATIENT SPECIFIC INSTRUMENTS HAS BEEN VALIDATED TO ACHIEVE SAL 10-6 AS PER ISO17665-1, AS PER OPT-RSK-16 V111. THERE WAS NO EVIDENCE TO SUGGEST THAT THE OPS TECHNOLOGY PROVIDED TO THE PRIMARY SURGERY MALFUNCTIONED OR WAS DEFICIENT. THIS FAILURE MODE IS NOT ASSOCIATED WITH THE USE OF OPS TECHNOLOGY IN THE PRIMARY SURGERY. THERE IS NO EVIDENCE TO SUGGEST THAT THE USE OF OPS TECHNOLOGY IN THE PRIMARY SURGERY CONTRIBUTED TO THIS REVISION EVENT. THEREFORE THE CASE IS NOW CONSIDERED CLOSED. THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SAME/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 THAT THE PATIENT WAS REVISED DUE TO INFECTION. OPS INSIGHT WITH ACETABULAR & FEMORAL GUIDES WERE USED AS AN ASSISTIVE TECHNOLOGY IN THE PRIMARY SURGERY.

    Additional Manufacturer Narrative · 1

    WE ARE CURRENTLY IN THE PROCESS OF RETRIEVING FURTHER INFORMATION TO PERFORM INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION. THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SAME/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 THAT THE PATIENT WAS REVISED DUE TO INFECTION. OPS INSIGHT WITH ACETABULAR & FEMORAL GUIDES WERE USED AS AN ASSISTIVE TECHNOLOGY IN THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632192 OPTIMIZED POSITIONING SYSTEM OPTIMIZED POSITIONING SYSTEM LZO OPTIMIZED ORTHO PTY LTD OPS INSIGHT MIN_MS_26606

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ACETABULAR GUIDE: 1248-1500| ACETABULAR GUIDE: 1248-1500| FEMORAL GUIDE: 1250-1100| FEMORAL GUIDE: 1250-1100