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

Catalog Number UNK ANKLE TALAR

Device Problems Loss of or Failure to Bond (1068); Use of Device Problem (1670); Malposition of Device (2616); Unintended Movement (3026); Migration (4003)

Patient Problems Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Date 01/01/2016

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.Investigation summary.No device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.(b)(4).

Event Description

The literature article entitled "short term results of the mobility total ankle system: clinical and radiographic outcome¿ written by yvonne r.A.Kerkhoff, et al; published in foot and ankle surgery, 22 pp 152-157 in 2016; was reviewed.The aim of the study was to determine the short-term results of the mobility total ankle system.More specific, short term results included the frequency of complications, reoperations and failure, the survival rate, patient reported outcomes and the prosthesis alignment.The article reports on 67 ankles (63 ankles followed up clinically) that were followed short-term radiographically after having a total ankle arthroplasty using the mobility total ankle system (depuy) between march 2008 and september 2013.Outcomes were assessed using patient reported outcomes, clinical evaluations and radiographic findings.There were two intraoperative complications that occurred.One was a fracture of the medial malleolus and one was a laceration of the flexor digitorum longus.Both cases were repaired intraoperatively and no problems were reported during follow-up.There were postoperative complications, excluding failures in 13 patients.Conservative treatment was sufficient for six of these and seven required a second operation.There was one deep infection which required operative debridement and polyethylene insert exchange within two months after the initial surgery.There was one case of subsidence of the talus component which required a subtalar arthrodesis with a bone graft in order to stabilize the component.There was also a case of a cyst located in the tibiofibular joint, which was treated with operative debridement and a bone graft.In four ankles, reoperation was necessary due to a painful impingement of the medial and/or lateral gutter.The time between surgery and the occurrence of complication was 1-29 months.Failure is defined as exchange of the tibial and/or talar components, occurred in three ankles.One patient had an early deep infection with a loose tibia component, which was treated with a two-stage revision of the tibia component.The two other patients continued their treatment in another hospital where one patient was treated with chronic ankle pain with an unknown cause and underwent amputation of the lower leg and the other patient had the prosthesis removed and ankle arthrodesis was conducted because of chronic pain and possible aseptic loosening.Radiographically, there was also four cases of malalignment observed of the tibial components and also five cases of talar malalignment.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: corrected: h6 (device codes).Product complaint (b)(4).Investigation summary : no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial 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: 9427992
• MDR Text Key: 185265203
• Report Number: 1818910-2019-121608
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention