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

Device Problem Missing Information (4053)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Literature citation: murray penner, md et al.The infinity total ankle system early clinical results with 2- to 4-year follow-up.Foot and ankle specialist.2018; volume 11: pages 1-7.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 "the infinity total ankle system early clinical results with 2- to 4-year follow-up" that 67 consecutive patients who underwent primary total ankle arthroplasty (taa) with the infinity system at 2 north american sites between august 2013 and may 2015 were reviewed in a prospective, observational study.Demographic, radiographic, and functional outcome data were collected preoperatively, at 6 to 12 months postoperatively, and annually thereafter.Results.The overall implant survival rate was 97% (65 of 67 implants) at a mean follow up of 35.4 months (27 to 47 months).Two (2) patients underwent unplanned procedures related to the 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: 7864568
• MDR Text Key: 119829111
• Report Number: 1043534-2018-00100
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2018

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/15/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/15/2018
• Initial Date FDA Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention