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

Device Problem Migration (4003)

Patient Problems Cyst(s) (1800); Bone Fracture(s) (1870); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Literature citation: guilherme h.Saito, et al.Short-term complications, reoperations, and radiographic outcomes of a new fixed-bearing total ankle arthroplasty.Foot and ankle international.2018; volume: 00 page(s)0 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, per saito et al in "short-term complications, reoperations, and radiographic outcomes of a new fixed-bearing total ankle arthroplasty" 64 patients underwent a total ankle replacement surgery.It was reported that 5 patients were treated for gutter impingement, 4 patients were treated for tibial subsidence, 1 patient treated for talar subsidence, 2 patients treated for post-op stress fracture, 1 patient treated for a tibial cyst, 1 patient was treated for hindfoot malalignment, 1 patient treated for superficial infection, and 1 patient treated for delayed wound healing.The average age of the patients was 61 (range of 31-81) and the avg follow up was 24.5 months (range 18-39).

• 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: 7691427
• MDR Text Key: 114092256
• Report Number: 1043534-2018-00063
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• 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: 04/02/2018
• Event Location: Hospital
• Date Manufacturer Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention