MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY TALAR DOME SZ 3 TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33630023
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "subject: (b)(6).Uk infinity® total ankle system study.Increased pain around medial side of ankle.Participant jumped to avoid stray golf ball last month and landed awkwardly on ankle.Intermittent pain has become regular around medial ankle and increased swelling.X-ray shows 'nothing untoward' with implant and participant listed for clearing medial gutter of bone due (b)(6) 2025.Update dated 07 may 2025: surgical intervention occurred on (b)(6) 2025 as scheduled.No implant removed.".
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.
Additional Manufacturer Narrative
The reported event could be confirmed based on provided 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.A review of the labeling did not indicate any abnormalities.Ifu clearly states that "patient¿s occupation or activity.If the patient is involved in an occupation or activity, which includes substantial walking, running, lifting, or muscle strain, the resultant forces can cause failure of the fixation or the device, or both.The prosthesis will not restore function to the level expected with normal healthy bone, and the patient should not have unrealistic functional expectations." no indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused due patient jumped and landed awkwardly.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "subject: (b)(6).Uk infinity® total ankle system study.Increased pain around medial side of ankle.Participant jumped to avoid stray golf ball last month and landed awkwardly on ankle.Intermittent pain has become regular around medial ankle and increased swelling.X-ray shows 'nothing untoward' with implant and participant listed for clearing medial gutter of bone due on (b)(6) 2025.Update dated 07 may 2025: surgical intervention occurred on (b)(6) 2025 as scheduled.No implant removed.".

• Brand Name: INFINITY TALAR DOME SZ 3 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; 1023 cherry rd; memphis TN 38117
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22020804
• Report Number: 3010667733-2025-00567
• Device Sequence Number: 8733974
• Product Code: HSN
• UDI-Device Identifier: 00840420122049
• UDI-Public: 00840420122049
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123954
• 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): 08/04/2025

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: 08/19/2025
• Device Catalogue Number: 33630023
• Device Lot Number: 1608040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2017
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 85 KG