MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ3 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/21/2025
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
Subject: (b)(6) stryker itar-2 study.Narrative of adverse event: patient reported falling off a curb on (b)(6) 2025, resulting in a closed fibula fracture of the right ankle, a small tendon tear of the right ankle, as well as self-reported pain/discomfort of the left ankle (study ankle).Right ankle fracture treatment (non-study ankle): the emergency room md placed the patient in a walking boot x 1 week, and after follow-up with an orthopaedic md, the patient was placed in an ankle brace x 2 weeks and prescribed physical therapy.The patient took tylenol prn.Right ankle tendon tear treatment (non-study ankle): patient returned to the orthopaedic md 3 months post-fracture diagnosis complaining of continued right ankle pain.Mri showed a small tendon tear and the original physical therapy script was extended to treat associated pain.Left ankle self-reported pain treatment (study ankle): orthopaedic md recommended physical therapy to help strengthen the ankle and reduce pain/discomfort.Ae status as of (b)(6) 2025: both right and left ankle pain are improving, but the patient continues to go to physical therapy.Planned reassessment of this ae (#6) at 2 year study visit scheduled (b)(6) 2025 with the surgeon.
Additional Manufacturer Narrative
The reported event be confirmed based on provided information in the event description.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.Based on investigation, the root cause was attributed to a patient related issue.The event states that the patient fell off a curb, broke the other fibula and tore the other ankle if the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Subject: (b)(6).Stryker itar-2 study.Narrative of adverse event: patient reported falling off a curb on (b)(6) 2025, resulting in a closed fibula fracture of the right ankle, a small tendon tear of the right ankle, as well as self-reported pain/discomfort of the left ankle (study ankle).Right ankle fracture treatment (non-study ankle): the emergency room md placed the patient in a walking boot x 1 week, and after follow-up with an orthopaedic md, the patient was placed in an ankle brace x 2 weeks and prescribed physical therapy.The patient took tylenol prn.Right ankle tendon tear treatment (non-study ankle): patient returned to the orthopaedic md 3 months post-fracture diagnosis complaining of continued right ankle pain.Mri showed a small tendon tear and the original physical therapy script was extended to treat associated pain.Left ankle self-reported pain treatment (study ankle): orthopaedic md recommended physical therapy to help strengthen the ankle and reduce pain/discomfort.Ae status as of july 2, 2025: both right and left ankle pain are improving, but the patient continues to go to physical therapy.Planned reassessment of this ae (#6) at 2 year study visit scheduled september 22, 2025, with the surgeon.

• Brand Name: INFINITY ADAPTIS TIB SZ3 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.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23347470
• Report Number: 3010667733-2025-01203
• Device Sequence Number: 12714590
• Product Code: HSN
• UDI-Device Identifier: 00889797069656
• UDI-Public: (01)00889797069656(11)230223(17)31028(10)1754836
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K181557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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 Catalogue Number: 33680003
• Device Lot Number: 1754836
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2023
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 83 KG