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.
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This complaint is from a literature source.The following literature cite has been reviewed: mahmoud k, metikala s, o'connor km, farber dc.Adverse events related to total ankle replacement devices: an analysis of reports to the united states food and drug administration.Int orthop.2021 sep;45(9):2307-2312.Doi: 10.1007/s00264-021-04972-z.Epub 2021 feb 11.Pmid: 33575857; pmcid: pmc8494697.Objective and methods: the published outcomes of total ankle replacement (tar) implants came from limited institutions creating observational bias.For broader perspective, the authors reviewed the food and drug administration's (fda) manufacturer and user facility device experience (maude) voluntary database to explore complications reported outside published literature associated with 6 different tar manufacturers reported on 648 med watch reports during november 1, 2011 and april 30, 2019.The authors searched the maude database utilizing the fda¿s device classification codes ntg and hsn for the depuy agility tar and 5 competitor constructs to determine the most common reason for adverse event reporting.This complaint will capture the 13 reports associated with the depuy agility tar.The authors do not provide sufficient information to determine the specific med watch report associated with each event.Additionally, there is insufficient information to determine the specifics of each adverse event, the treatments/interventions, and/or the exact devices associated with the events.The following events were reported to the fda as serious injuries or malfunctions.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 and one ankle alignment instrument adverse event(s) and provided interventions associated with depuy devices: 1 report of aseptic loosening of an unknown device, 6 reports due to alignment/mechanical issues including instability and malposition, 1 report due to implant/instrumentation associated with intraoperative alignment instrumentation and possible tibial fracture, 1 report associated with impingement with could include soft tissue impingement and/or heterotopic ossification.
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