BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9448678 · Received December 10, 2019

    Report

    Report Number
    3012916784-2019-00032
    Event Type
    Injury
    Date Received
    December 10, 2019
    Date of Event
    November 19, 2019
    Report Date
    January 16, 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 RECEIVED PRIMARY SURGERY ON (B)(6) 2017, EXPERIENCED MULTIPLE DISLOCATIONS AND WAS REVISED ON (B)(6) 2019. PATIENT RECEIVED THE USE OF THE OPS PLAN (K183038), PATIENT SPECIFIC ACETABULAR GUIDE (K152893), PATIENT SPECIFIC FEMORAL GUIDE (K181061), AND FUNCTIONAL HIP ANALYSIS (FHA) REPORT (K152893) IN THE PRIMARY SURGERY. A ROOT CAUSE INVESTIGATION WAS CONDUCTED IN THIS ISSUE. POST-OPERATIVE IMAGING WAS PROVIDED AND REVIEWED AS PART OF THIS INVESTIGATION. NO ISSUE WAS FOUND WITH THE ACHIEVED IMPLANT POSITIONING THAT WOULD SUGGEST THE PATIENT WOULD AT RISK OF DISLOCATING. THE PRE-OPERATIVE PLANNING WAS ALSO REVIEWED AS PART OF THIS INVESTIGATION. ALL PROCESSING OF THIS PLANNING WAS FOUND TO BE PERFORMED WITHIN WORK INSTRUCTIONS, AND ALL PRODUCTS PROVIDED WERE CONFIRMED TO HAVE BEEN MANUFACTURED TO SPECIFICATION. NO ISSUE WAS FOUND WITH THE OPS TECHNOLOGY PROVIDED TO THE PRIMARY SURGERY THAT MAY HAVE LEAD TO THIS ADVERSE EVENT. THE ROOT CAUSE OF THIS ISSUE WAS UNABLE TO BE DETERMINED. 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 RECEIVED PRIMARY SURGERY ON (B)(6) 2017, EXPERIENCED MULTIPLE DISLOCATIONS AND WAS REVISED ON (B)(6) 2019. PATIENT RECEIVED THE USE OF THE OPS PLAN (K183038), PATIENT SPECIFIC ACETABULAR GUIDE (K152893), PATIENT SPECIFIC FEMORAL GUIDE (K181061), AND FUNCTIONAL HIP ANALYSIS (FHA) REPORT (K152893) IN THE PRIMARY SURGERY. A ROOT CAUSE INVESTIGATION WAS CONDUCTED IN THIS ISSUE. POST-OPERATIVE IMAGING WAS PROVIDED AND REVIEWED AS PART OF THIS INVESTIGATION. NO ISSUE WAS FOUND WITH THE ACHIEVED IMPLANT POSITIONING THAT WOULD SUGGEST THE PATIENT WOULD AT RISK OF DISLOCATING. THE PRE-OPERATIVE PLANNING WAS ALSO REVIEWED AS PART OF THIS INVESTIGATION. ALL PROCESSING OF THIS PLANNING WAS FOUND TO BE PERFORMED WITHIN WORK INSTRUCTIONS, AND ALL PRODUCTS PROVIDED WERE CONFIRMED TO HAVE BEEN MANUFACTURED TO SPECIFICATION. NO ISSUE WAS FOUND WITH THE OPS TECHNOLOGY PROVIDED TO THE PRIMARY SURGERY THAT MAY HAVE LEAD TO THIS ADVERSE EVENT. THE ROOT CAUSE OF THIS ISSUE WAS UNABLE TO BE DETERMINED.

    Additional Manufacturer Narrative · 1

    PATIENT RECEIVED PRIMARY SURGERY (B)(6) 2017, EXPERIENCED MULTIPLE DISLOCATIONS AND WAS REVISED ON (B)(6) 2019. PATIENT RECEIVED THE USE OF THE OPS PLAN (K183038), PATIENT SPECIFIC ACETABULAR GUIDE (K152893), PATIENT SPECIFIC FEMORAL GUIDE (K181061), AND FUNCTIONAL HIP ANALYSIS (FHA) REPORT (K152893) IN THE PRIMARY SURGERY.

    Description of Event or Problem · 1

    PATIENT RECEIVED PRIMARY SURGERY (B)(6) 2017, EXPERIENCED MULTIPLE DISLOCATIONS AND WAS REVISED ON (B)(6) 2019. PATIENT RECEIVED THE USE OF THE OPS PLAN (K183038), PATIENT SPECIFIC ACETABULAR GUIDE (K152893), PATIENT SPECIFIC FEMORAL GUIDE (K181061), AND FUNCTIONAL HIP ANALYSIS (FHA) REPORT (K152893) IN THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242980 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD 1248-1500 FRA_MI_6694H

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention