MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN ANKLE TALAR

Catalog Number UNK ANKLE TALAR

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Osteolysis (2377); No Code Available (3191)

Event Date 01/01/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

The literature article entitled " salvage of a failed depuy alvine total ankle prosthesis with agility lp custom stemmed tibia and talar components¿, written by thomas s.Roukis, dpm, phd, published in clinical podiatry med surg 30 (2013), 101-109, was reviewed.The article presents a case of revision of a phase 2 version of the depuy alvine total ankle prosthesis (depuy) to a custom-designed stemmed tibial and talar component agility lp total ankle replacement system (depuy).The patient sustained a left-sided pronation-abduction ankle fracture dislocation following a fall from a height and underwent open reduction with internal fixation in 1994.He developed distal-lateral tibial osteonecrosis and advanced degenerative joint disease that was debilitating.Following removal of the retained deep internal fixation, he underwent primary implantation of a size-3 depuy alvine total ankle prosthesis at age 56 years.The tibial component subsequently developed subsidence with anterior angulation, and the talar component developed subsidence with varus angulation.The radiograph showed extensive syndesmosis arthrodesis, aseptic osteolysis and gross loosening of the tibial and talar components, with severe subsidence of the tibial component into the distal tibial metaphysis and severe varus deformity of the hindfoot originating from the ankle.Clinical evaluation revealed severely restricted range of motion with an osseous end to both dorsiflexion and plantarflexion motion as well as lateral ankle instability emanating from the ankle and subtalar joint.He was initially treated with functional brace therapy and lateral insole wedging that failed to provide relief.Due to this, the patient had an agility lp custom-design stemmed tibial and talar component total ankle replacement with lateral ankle stabilization implanted.Except for some rebound peripheral edema once immobilization began, no complications occurred, and the patient progressed to return to full ambulation.After one-year follow-up, the patient remains pain free, has acceptable range of motion and is well aligned.This patient had two depuy implants and both will be addressed on this complaint.

Manufacturer Narrative

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.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN ANKLE TALAR
• Type of Device: ANKLE TALAR
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9468109
• MDR Text Key: 185533869
• Report Number: 1818910-2019-121222
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ANKLE TALAR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention