Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
This complaint is from a literature source.The following literature cite has been reviewed: benson a, alvine f, alvine g.Sixteen-year follow-up of talar body prosthesis and total ankle arthroplasty after traumatic talar extrusion: a case report.Jbjs case connect.2021 mar 3;11(1).Doi: 10.2106/jbjs.Cc.20.00543.Pmid: 33657023.Objective and methods: (b)(6) patient received a custom agility total ankle replacement 2 tears after accidental excision of her natural talus in 2002.The patient received a talar component, tibial component, talar stem, and tibial insert in addition to a tibial-fibular syndesmosis fused with allograft and two unknown screws.In 2009, the patient experienced pain and swelling and x-rays revealed a collapsed tibial component rotated into valgus alignment.No treatment was provided as the pain resolved.In 2019, the patient again reported pain and joint instability.A ct scan revealed subluxation and impingement secondary to wear of the tibial insert.Upon entering the joint, metallosis due to articulation on the talar component on the tibial component secondary to tibial insert wear was identified and debrided.There was some navicular bone erosion noted.The tibial and talar components were well-fixed, with some wear, and retained.The migration of the tibial component and joint laxity was confirmed.The patient received a revision of the poly insert.The procedure was completed without complications.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: agility ankle: tibial component, tibial insert, talar component, talar stem.
|