Company was notified of a revision surgery.An investigation was performed including internal analysis of records and the surgeon's feedback.The device could not be examined as it was not provided to the company.Imaging provided at 1w showed good bone alignment, at 6w showed loss of reduction.No report of trauma.During revision surgery it was reported that the implant was found broken, the revision was completed successfully.There is no indication of a design, manufacturing or process issue affecting implant safety or effectiveness.Based on surgeon's feedback the root cause of the revision surgery is likely related to incorrect implant size selection for the patient, using an implant too small for the patient bone size, combined with permissive post-operative care regime, which may lead to unstable fixation and result in revision surgery.However, as a revision surgery was performed and because the company cannot rule out the possible contribution of the device to the event, out of an abundance of caution, this event is being reported.Company continues to monitor these events as part of post market activities.Additional reports relating to this event are: # 3014554088-2024-00001/2, #3014323288-2024-00002.
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