MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY POLY SZ 4+ 7MM TOTAL ANKLE SYSTEM; Prosthesis, ankle, semi-constrained, cemented, metal/polymer

Catalog Number	33655407
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Joint Laxity (4526)
Date of Event	01/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject: (b)(6) uk infinity® total ankle system study.(b)(6) 2018.Instability in right ankle with ongoing pain.Very poor bone quality.Lack of bone integration into prodense grafting in the right ankle.Strong history of infection in knee.Patient was due to be admitted to rule out poor bone integration versus infection in the ankle, however patient did not wish to proceed.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.

• Brand Name: INFINITY POLY SZ 4+ 7MM TOTAL ANKLE SYSTEM
• Common Device Name: Prosthesis, ankle, semi-constrained, cemented, metal/polymer
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): Wright Medical Technology, Inc.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25841016
• Report Number: 3010667733-2026-00943
• Device Sequence Number: 10417156
• Product Code: HSN
• UDI-Device Identifier: 00840420122827
• UDI-Public: (01)00840420122827(11)170217(17)250215(10)1590831
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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 Expiration Date: 02/15/2025
• Device Catalogue Number: 33655407
• Device Lot Number: 1590831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 07/16/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 182 LB