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

Catalog Number	33680021
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Loss of Range of Motion (2032); Implant Pain (4561)
Date of Event	08/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the prosthesis appears to have subsided anteriorly.Patient states that she has soreness at the medial and lateral aspect of her right ankle.She notes that she has cut back on formal pt, attending once weekly due to soreness.She notes her concerns about overworking her ankle.Patient notes that she only began aggressive exercises the last 2 to 4 times she has last been at pt.Prior to surgical treatment patient notes stiffness and limited rom of her ankle.However, she notes improvement of ankle rom.

• 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: 12418138
• Report Number: 0001043534-2021-00169
• Device Sequence Number: 11661133
• Product Code: HSN
• UDI-Device Identifier: 00889797101516
• UDI-Public: 00889797101516
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K172633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/02/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 33680021
• Device Lot Number: 1683232
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 09/02/2021
• 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: Other
• Patient Age: 58 YR
• Patient Weight: 54