BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACETABULAR GUIDE

    MDR report key: 15967813 · Received December 13, 2022

    Report

    Report Number
    3012916784-2022-00157
    Event Type
    Injury
    Date Received
    December 13, 2022
    Date of Event
    December 2, 2022
    Report Date
    February 21, 2023
    Manufacturer
    OPTIMIZED ORTHO PTY LTD.
    Product Code
    PBF
    PMA / PMN Number
    K202805
    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. 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.

    Additional Manufacturer Narrative · 0

    OPTIMIZED ORTHO¿S MANUFACTURERS REPORT: NO COMPLAINT DEVICES WERE RETURNED TO OPTIMIZED ORTHO BY THE CUSTOMER. THUS, THE DEVICE PROCESSING FILES WERE INVESTIGATED WHICH INCLUDED REVIEWING OPS PROCESSES, AND ANY AVAILABLE 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. 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION STILL IN PROGRESS AS OF (B)(6) 2023.

    Description of Event or Problem · 0

    LEFT SIDE FIRST STAGE HIP REVISION DUE TO INFECTION. ALL IMPLANTS EXPLANTED. PRIMARY DEVICE INFO TRINITY CUP 50MM TAPER SIZE 3, PART #: 321.03.350, LOT #: 483656, ARTG # 235377 (EXPLANTED); TRINITY CERAMIC LINER 36MM TAPER 3, PART #: 321.03.436, LOT #: 492483, ARTG #: 210774 (EXPLANTED); METAFIX COLLARED STD 125 SIZE 2, PART #: 579.2102, LOT #: 489725, ARTG #: 281110 (EXPLANTED); TRINITY CERAMIC HEAD SHORT 36MM -4MM, PART #: 104.3600, LOT #: 498948, ARTG #: 211371 (EXPLANTED); OPS INSIGHT + ACE GUIDE + FEM GUIDE, PART #: 1200-0000, 1248-0500, 1250-0100, LOT #: ISD_AX_58087, ARTG # 323911; PRIMARY SURGERY INFO: CASE #: (B)(6), HOSPITAL: (B)(6), DATE: (B)(6) 2022, SURGEON: (B)(6).

    Description of Event or Problem · 0

    ISD_AX_58087 REVISION DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425568 ACETABULAR GUIDE ORTHOPAEDIC IMPLANTATION APPLICATION SOFTWARE PBF OPTIMIZED ORTHO PTY LTD. 1248-0500 ISD_AX_58087

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention FEMORAL GUIDE