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

Catalog Number	33680005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Osteolysis (2377); Swelling/ Edema (4577)
Date of Event	07/21/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• MDR Report Key: 12568607
• Report Number: 0001043534-2021-00193
• Device Sequence Number: 14251017
• Product Code: HSN
• UDI-Device Identifier: 00889797069670
• UDI-Public: 00889797069670
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K181557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2021

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 33680005
• Device Lot Number: 1704629
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 149