BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMIZED POSITIONING SYSTEM

    MDR report key: 10377280 · Received August 6, 2020

    Report

    Report Number
    3012916784-2020-00066
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    July 14, 2020
    Report Date
    September 1, 2020
    Manufacturer
    OPTIMIZED ORTHO PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    K181061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    METHOD: NO COMPLAINT DEVICES WERE RETURNED TO OPTIMIZED ORTHO BY THE CUSTOMER. THUS, THE DEVICE HISTORY FILES WERE INVESTIGATED WHICH INCLUDED REVIEWING THE OPS PLAN, DYNAMIC HIP ANALYSIS REPORT, PRE AND POST OPERATIVE IMAGING OF THE PATIENT, OPS ACETABULAR AND FEMORAL GUIDES. ALL MANUFACTURING STEPS OF IMPLANT POSITIONING AND REPORT GENERATION WERE REVIEWED. CONCLUSION: ALL OPERATIONS WERE COMPLETED CORRECTLY ACCORDING TO THE WORK INSTRUCTIONS. NO DEFICIENCY WAS FOUND WITH ANY OF THE OPS RELATED PROCESSES OR ACETABULAR OR FEMORAL GUIDE. DISLOCATION AFTER A TOTAL HIP ARTHROPLASTY (THA) IS INFLUENCED BY MULTIPLE FACTORS. THESE INCLUDE THE POSITIONING OF THE ACETABULAR COMPONENT, THE POSITIONING OF THE FEMORAL COMPONENT, THE ANATOMY OF THE PATIENT, AND THE LIFESTYLE OF THE PATIENT POST OPERATION. AS SUCH, THERE ARE MULTIPLE FACTORS THAT MAY HAVE CONTRIBUTED TO THE DISLOCATION WHICH ARE OUTSIDE THE SCOPE OF THIS INVESTIGATION. THE DHA REPORT FOR THIS PATIENT WARNS THAT THE PATIENT DEMONSTRATES A SIGNIFICANT PELVIC ROTATION OF 14 DEGREES FROM SUPINE TO STAND. LARGE PELVIC ROTATIONS HAVE BEEN FOUND IN THE LITERATURE TO BE A RISK FACTOR FOR DISLOCATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A CORIN REPRESENTATIVE THAT THE PRIMARY SURGERY WAS HELD ON THE (B)(6) 2019. WHERE OPS TECHNOLOGY (OPS PLAN WITH DHA & ACETABULAR & FEMORAL GUIDES) WERE USED AS ASSISTIVE TECHNOLOGY. HOWEVER, RECENTLY THE PATIENT DISLOCATED AND THE SURGEON PERFORMING THE REVISION SURGERY COMMENTED THAT THERE WAS LITTLE BONE IN-GROWTH ON THE CUP. THE TRINITY CUP WAS REPLACED WITH A STRYKER 50MM TRITANIUM CUP WITH SCREWS AND A CONSTRAINED LINER. OPS TECHNOLOGY WAS NOT USED FOR THE REVISION SURGERY.

    Additional Manufacturer Narrative · 1

    WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CORIN REPRESENTATIVE THAT THE PRIMARY SURGERY WAS HELD ON (B)(6) 2019. WHERE OPS TECHNOLOGY (OPS PLAN WITH DHA & ACETABULAR & FEMORAL GUIDES) WERE USED AS ASSISTIVE TECHNOLOGY. HOWEVER, RECENTLY THE PATIENT DISLOCATED AND THE SURGEON PERFORMING THE REVISION SURGERY COMMENTED THAT THERE WAS LITTLE BONE IN-GROWTH ON THE CUP. THE TRINITY CUP WAS REPLACED WITH A STRYKER 50MM TRITANIUM CUP WITH SCREWS AND A CONSTRAINED LINER. OPS TECHNOLOGY WAS NOT USED FOR THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841450 OPTIMIZED POSITIONING SYSTEM OPTIMIZED POSITIONING SYSTEM LZO OPTIMIZED ORTHO PTY LTD MEP_OE_19566

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention