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

Catalog Number 33680005

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Osteolysis (2377); Swelling/ Edema (4577)

Event Date 07/21/2021

Event Type  Injury  

Manufacturer Narrative

The device remains implanted in the patient. If additional information becomes available, it will be provided on a supplemental report. Device remains implanted in patient.

Event Description

It was reported that the patient experienced a spontaneous increase in swelling and pain which was exacerbated 2 days later. The patient reports increased swelling is very apparent when showering. The surgeon obtained an xray of the foot which showed a medial malleolar stress fracture. Patient was placed in a fracture boot. Rice treatment. 8 days later it was reported that the patient was worsening. The patient notes increasing pain at the medial malleolus and fracture site, exacerbated by weight bearing. X-rays taken which show an abundant periosteal reaction about the medial malleolus fracture and increased lucency at fracture line. Total ankle prosthesis appears stable. Treatment options were discussed. Discussed observation with wbat in fracture boot vs nwb with crutches vs surgical treatment. The patient underwent an orif medial malleolus six days later. Adverse event is improving. 2 week follow-up of right medial malleolus stress fracture s/p orif medial malleolus. Patient had a right ankle replacement with deformity correction. Patient is doing well, making expected progress and pain is well-controlled.

• Brand Name: INFINITY ADAPTIS 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: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12568607
• MDR Text Key: 274489944
• Report Number: 0001043534-2021-00193
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797069670
• UDI-Public: 00889797069670
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 33680005
• Device Lot Number: 1704629
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/04/2021 Patient Sequence Number: 1