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 Codes	Neuropathy (1983); Numbness (2415)
Date of Event	02/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.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.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Infinity¿ with adaptis¿ technology total ankle replacement follow-up (itar2) study: subject (b)(6).Patient sent a message to the clinical team on (b)(6) 2023 reporting inability to do heel lifts due to lack of strength.She also reported numbness that runs the length of her shin bone on the front of her leg.An emg was scheduled (b)(6) 2023, due to patient travel beforehand.Emg showed evidence of left sciatic mononeuropathy affecting the tibial fascicles more than the peroneal fascicles, localized to the popliteal fossa.Patient had initial visit with peripheral nerve injury clinic on (b)(6) 2023.Patient will continue physical therapy to improve symptoms, medication and intervention were not recommended.Update 16 jan 2026: 30-oct-2025: ¿numbness and tingling in the left leg and foot have improved since the last visit.Symptoms are likely due to a nerve injury sustained during the ankle replacement surgery that is permanent, thus classifying it a serious adverse event.The nerve injury is focal, primarily affecting one nerve root, contributing to pain and stiffness.The neurogenic element is better than before but not perfect.Did this adverse event meet the criteria of a serious adverse event during the time period since the last report? : yes¿.
Event or Problem Description
Infinity¿ with adaptis¿ technology total ankle replacement follow-up (itar2) study: subject (b)(6).Patient sent a message to the clinical team on (b)(6) 2023 reporting inability to do heel lifts due to lack of strength.She also reported numbness that runs the length of her shin bone on the front of her leg.An emg was scheduled (b)(6) 2023, due to patient travel beforehand.Emg showed evidence of left sciatic mononeuropathy affecting the tibial fascicles more than the peroneal fascicles, localized to the popliteal fossa.Patient had initial visit with peripheral nerve injury clinic on (b)(6) 2023.Patient will continue physical therapy to improve symptoms, medication and intervention were not recommended.Update 16 jan 2026: 30-oct-2025 ¿numbness and tingling in the left leg and foot have improved since the last visit.Symptoms are likely due to a nerve injury sustained during the ankle replacement surgery that is permanent, thus classifying it a serious adverse event.The nerve injury is focal, primarily affecting one nerve root, contributing to pain and stiffness.The neurogenic element is better than before but not perfect.Did this adverse event meet the criteria of a serious adverse event during the time period since the last report? : yes¿.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.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.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided the investigation will be reassessed.

• 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: 24323842
• Report Number: 3010667733-2026-00106
• Device Sequence Number: 9523466
• Product Code: HSN
• UDI-Device Identifier: 00889797069656
• UDI-Public: (01)00889797069656(11)221027(17)301027(10)1744954
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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: 1744954
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2022
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 67 KG