In the month of january (2019) orthalign, inc.Was made aware of 6 patients who underwent unicompartmental knee arthroplasty surgery that utilized orthalign inc.'s orthalign plus®, unialign¿ system performed by dr.(b)(6) of (b)(6) in (b)(6).These six patients were discovered to have induced tibial plateau fractures at post-operative appointments.Once orthalign was made aware of these cases dr.(b)(6) was immediately contacted to gather more information.Through investigating these six incidences orthalign cannot verify the initial complaint regarding the kneealign® 2 instrumentation.A risk assessment was performed, and internal risk documents were reviewed.The known risk of bone fractures in unicompartmental knee arthroplasty's is addressed specific to pin placement.The placement of pins per the instrumentation instruction has been assessed and validated by surgeons.Through the third-party investigation performed with dr.(b)(6), orthalign gathered the following information: no noted device defects or malfunctions were detected.The orthalign instruments performed as expected.The instruments have also been used in other cases without any problems.The unialign instruments were used with the orthalign plus unit and ka2 instruments set per standard procedure.The surgeon fixated the instrumentation appropriately.No notable intraoperative challenges and observations were detected during the case.No complicating factors were observed.No other relevant patient history or medical conditions was noted.Patient x-rays and two images from one of the cases were received.Fractures propagated at the plateau base, but not from where pins were placed.There is no known cause of the tibial fractures and no immediate device related cause or contribution to these events.Orthalign is filing this mdr in an abundance of caution due to the outcome of these cases and the potential connection to the unialign¿ system.
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