BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPS

    MDR report key: 17477754 · Received August 8, 2023

    Report

    Report Number
    3012916784-2023-00186
    Event Type
    Injury
    Date Received
    August 8, 2023
    Date of Event
    July 27, 2023
    Report Date
    December 4, 2023
    Manufacturer
    OPTIMIZED ORTHO PTY LTD.
    Product Code
    PBF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) : FINAL REPORT. NO DEFICIENCY WAS FOUND WITH ANY OF THE OPS RELATED PROCESS. THE OPS PLAN, DHA REPORT, PSV REPORTS AND THE ASSOCIATED PSI GUIDES WERE ALL DESIGNED TO SPECIFICATION AND THERE IS NO INDICATION AS TO WHY THE PATIENT ENDED UP BEING 15MM LONG. THE OPS PLAN HAD AN INITIAL 3MM LENGTHENING PLANNED AND WITHOUT POST-OPERATIVE IMAGING, IT IS NOT CLEAR WHY OR HOW THE PATIENT REPORTED A SIGNIFICANT LEG LENGTH DISCREPANCY. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE DISCREPANCY IS UNRELATED TO THE OPS TECHNOLOGY AS NO ISSUE WAS FOUND WITH THE PROCESSING OF THE OPS PLAN. THEREFORE, THE CASE IS NOW CONSIDERED CLOSED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE 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. 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

    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.

    Description of Event or Problem · 0

    REVISION HIP SURGERY DUE TO LEG LENGTH DISCREPANCY. ALL IMPLANTS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457667 OPS ORTHOPAEDIC SURGICAL PLANNING AND INSTRUMENT GUIDES PBF OPTIMIZED ORTHO PTY LTD. 1250-1300 STO_DP_19578

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention OPS ACETABULAR GUIDE - 1248-0500| OPS FEMORAL GUIDE - 1250-0100