MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Device Problem Migration (4003)

Patient Problem Fall (1848)

Event Type  Injury  

Manufacturer Narrative

Literature citation: minimum two-year results of a fixed-bearing total ankle arthroplasty.Foot and ankle international.Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Event Description

Allegedly, it was reported in "minimum two-year results of a fixed-bearing total ankle arthroplasty" that thirty-one (31) primary infinity taas were performed beginning july 2014 in 19 males and 12 females with a minimum clinical follow-up of 24 (range, 24-35) months.The average age of 31 patients was 67 (range, 44-87) years.Cofas classification was 1 (n = 9), 2 (n = 8), 3 (n = 2), or 4 (n = 12).The indication for surgery was primary osteoarthritis in 15 cases, posttraumatic arthritis in 14 cases, and inflammatory arthritis in 2 cases.One patient required staged tibial deformity correction prior to taa.Additional procedures included 1 lateral ligament stabilisation, 1 calcaneal osteotomy and 2 gastrocnemius lengthenings.There was 1 medium-grade complication of tibial component subsidence.This was early traumatic subsidence resulting from a fall on day 2 postoperatively and required reoperation including revision of both components to an inbone taa.

• Brand Name: INFINITY TOTAL ANKLE SYSTEM
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: 1023 cherry road; memphis, TN 38117 ; 9014516318
• MDR Report Key: 7870146
• MDR Text Key: 120000355
• Report Number: 1043534-2018-00104
• 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,literature
• Type of Report: Initial
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/15/2018
• Event Location: Hospital
• Date Manufacturer Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1