MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC FLAT CUT TALAR DOME SZ 1 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680031
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Discomfort (2330); Implant Pain (4561); Swelling/ Edema (4577); Joint Impingement (4834)
Date of Event	04/09/2024
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: stryker itar-2 subject: (b)(6).During 2y follow-up visit on (b)(6) 2024, subject reported increasing pain and swelling to the inside aspect of the left ankle.Musculoskeletal exam indicated diffuse tenderness to the medial region of the left ankle and significant discomfort to the medial gutter.Imaging results showed a stable appearing left total ankle replacement with no lucency around the hardware.Possible impingement of the medial gutter was noted.Subject will continue to follow-up with surgeon and if pain continues the patient could require medial gutter debridement or possibly a spect ct scan.Subject was prescribed meloxicam for pain.
Event or Problem Description
As reported: "(b)(6).During 2y follow-up visit on (b)(6) 2024, subject reported increasing pain and swelling to the inside aspect of the left ankle.Musculoskeletal exam indicated diffuse tenderness to the medial region of the left ankle and significant discomfort to the medial gutter.Imaging results showed a stable appearing left total ankle replacement with no lucency around the hardware.Possible impingement of the medial gutter was noted.Subject will continue to follow-up with surgeon and if pain continues the patient could require medial gutter debridement or possibly a spect ct scan.Subject was prescribed meloxicam for pain.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.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.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 device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: FLAT CUT TALAR DOME SZ 1 INFINITY ADAPTIS
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21035642
• Report Number: 3010667733-2024-01107
• Device Sequence Number: 7655960
• Product Code: HSN
• UDI-Device Identifier: 00889797073059
• UDI-Public: 00889797073059
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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: 33680031
• Device Lot Number: 1718309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2021
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 99 KG