MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY POLY SZ 4+ 7MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	33655407
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Fibrosis (3167)
Date of Event	01/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "study: uk infinity® total ankle system subject: 700-001.Stiff ankle with significant arthrofibrosis front and back.Ankle.Arthroscopy resecting scar tissue.No complications".
Additional Manufacturer Narrative
The reported event could be confirmed based on available information the device inspection was not possible as the product was not returned for investigation a review of the device history for the reported lot did not indicate any abnormalities no corrective actions are required at this time no indications of material manufacturing or design related problems were found during the investigation a review of the labeling did not indicate any abnormalities more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event if the device is returned or if any additional information is provided the investigation will be reassessed.
Event or Problem Description
As reported: "study: uk infinity® total ankle system subject: 700-001 stiff ankle with significant arthrofibrosis front and back.Ankle.Arthroscopy resecting scar tissue.No complications".

• Brand Name: INFINITY POLY SZ 4+ 7MM TOTAL ANKLE SYSTEM
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20407852
• Report Number: 3010667733-2024-00691
• Device Sequence Number: 6545984
• Product Code: HSN
• UDI-Device Identifier: 00840420122827
• UDI-Public: 00840420122827
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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: 01/21/2025
• Device Catalogue Number: 33655407
• Device Lot Number: 1587850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2017
• 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: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 51 KG