BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMIZED POSITIONING SYSTEM

    MDR report key: 13297319 · Received January 19, 2022

    Report

    Report Number
    3012916784-2022-00111
    Event Type
    Malfunction
    Date Received
    January 19, 2022
    Date of Event
    December 16, 2021
    Report Date
    March 30, 2022
    Manufacturer
    OPTIMIZED ORTHO PTY LTD
    Product Code
    PBF
    PMA / PMN Number
    K192656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    NO COMPLAINT DEVICES WERE RETURNED TO OPTIMIZED ORTHO BY THE CUSTOMER. THUS, THE DEVICE PROCESSING FILES WERE INVESTIGATED WHICH INCLUDED REVIEWING OPS PROCESSES, OPS ACETABULAR AND FEMORAL GUIDES, AND PRE AND POST OPERATIVE IMAGING OF THE PATIENT. THE DESIGN OF PATIENT SPECIFIC GUIDES HAS 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. ACETABULAR GUIDE AND FEMORAL GUIDE DELIVERY PRODUCTS WERE DESIGNED WITHIN SPECIFICATION. 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 AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    (B)(4) LINER AND HEAD EXCHANGE DUE TO INFECTION.

    Description of Event or Problem · 0

    HAR_BP_55209 - LINER AND HEAD EXCHANGE DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70173 OPTIMIZED POSITIONING SYSTEM OPTIMIZED POSITIONING SYSTEM PBF OPTIMIZED ORTHO PTY LTD OPSINSIGHT HAR_BP_55209

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention OPS FEMORAL GUIDE| OPS FEMORAL GUIDE