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

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Literature citation: cody et al.Increased early revision rate with the infinity total ankle prosthesis.Foot & ankle international.2018.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 by cody et al.In an article titled "increased early revision rate with the infinity total ankle prosthesis" it was reported that sixteen ankles (10%) in 15 patients with a mean age of 63 years (range, 45-78 years) underwent revision a mean 13 months postoperatively (range, 2-28 months), divided proportionately between the 2 surgeons such that each surgeon had a 10% revision rate.Revision was performed most commonly for symptomatic (painful) tibial component loosening (6 ankles, 3.8%) and deep infection (6 ankles, 3.8%).

• 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: 7927774
• MDR Text Key: 122387594
• Report Number: 1043534-2018-00156
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/12/2018
• Event Location: Hospital
• Date Manufacturer Received: 09/12/2018
• 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
• Patient Outcome(s): Required Intervention