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 Pain (1994)

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).Revision of metal components was performed for aseptic loosening and persistent pain in 2 cases.The first case showed subtle lucency at the posterior aspect of the talar component only on ct scan, but no change in component position.Talar component loosening was identified intraoperatively, though the tibial component remained well fixed.Isolated talar component revision with an inbone ii talar component was performed at 24 months postoperatively.In the second case, the tibial component was seen to subside into dorsiflexion by 7° on radiographs, and ct scan demonstrated subtle osteolysis adjacent to both the talar and tibial components.Intraoperatively both the talar and tibial components were found to be loose and were revised with inbone ii tibial and talar components at 22 months postoperatively.

• 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: 7864570
• MDR Text Key: 119830987
• Report Number: 1043534-2018-00097
• 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

• Date FDA Received: 09/11/2018
• 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: 08/15/2018
• Event Location: Hospital
• Date Manufacturer Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention