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

Catalog Number	33650013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Impaired Healing (2378); Post Operative Wound Infection (2446)
Date of Event	01/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
The patient needed to use prosthesis during the ankle replacement, and the tibial pad was used during the procedure, and the replacement results were good.Later after 1 month the incision was permeated and the healing was poor.Re-admitted to hospital for debridement, antibiotic bone cement placement, vsd aspiration.Postoperative wound recovery was ok.
Additional Manufacturer Narrative
The reported event could not be confirmed since the affected device was not returned for evaluation and no other evidence was provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required currently.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design-related problems were found during the investigation.Microbiologist reviewed the sterilization procedures, environmental monitoring, bioburden data and the dhr and noted: the subject device was packaged according to established design and process specifications, and was sterilized according to procedure.No deviation for a non-conformance could be found.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.If the device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
The patient needed to use prosthesis during the ankle replacement, and the tibial pad was used during the procedure, and the replacement results were good.Later after 1 month the incision was permeated and the healing was poor.Re-admitted to hospital for debridement, antibiotic bone cement placement, vsd aspiration.Postoperative wound recovery was ok.

• Brand Name: INFINITY TIBIAL TRAY SZ 3 LNG 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21911991
• Report Number: 3010667733-2025-00497
• Device Sequence Number: 13022350
• Product Code: HSN
• UDI-Device Identifier: 00840420122544
• UDI-Public: (01)00840420122544(11)240517(17)320517(10)1779890
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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 Catalogue Number: 33650013
• Device Lot Number: 1779890
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2024
• 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 Sex: Unknown