Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 10 states, ¿loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.¿.
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It was reported that patient underwent a left partial knee arthroplasty on (b)(6) 2014.Patient underwent a right knee arthroplasty on an unknown date.Subsequently, patient received an injection on an unknown date due to disease progression at the lateral compartment.No revision procedure scheduled to date.Additional information received has indicated a revision procedure due to bone scarring and tibial loosening may occur; however, no revision has been reported at this time.
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