On 20 october 2017 the medical affairs performed a clinical evaluation and commented as follows: subsidence of collared femoral stem 2 days after primary cementless tha.The causes for subsidence are not known; one possibility is stem undersizing and insufficient cortical contact, but bone conditions may also play a role.Only one radiographical projection is available, insufficient for full assessment.This type of problem should not be ascribed to a faulty implant.Batch review performed on 30 october 2017.Lot 171636: (b)(4) items manufactured and released on 28 june 2017.Expiration date: 2022-05-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
|