MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ4LNG INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680014
Medical Device Problem Codes	Fracture (1260); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Implant Pain (4561)
Date of Event	01/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject: (b)(6).Infinity with adaptis (itar2) study.Adverse event: implant failure result date: (b)(6) 2025 there is an infinity total ankle with a previous calcaneal osteotomy.The talar component is well-fixated and unchanged compared to previous images.However, the tibial component has a fractured posterior peg that was not present on x-rays taken 1 year ago.There are also lucencies about the tibial tray which were present previously.This suggests a loose tibial tray.Multiple previous x-rays, including index imaging, are today reviewed and compared to current imaging to discern bony healing, changes in alignment, and overall radiographic status.This review and comparison are intrinsic to today's evaluation and decision making.Assessment the patient is a nice 64 y.O., female with right ankle pain.Diagnosis: ~3 years s/p right tar (dos: (b)(6) 2022) data reviewed: today's xrays and previous sets of xrays.The applicable imaging was reviewed with the patient.Discussion/plan: the patient presents today for her 3-year follow up of her right ankle replacement.She notes occasional achy pain as well as bruising in the lateral ankle.On physical examination, ankle motion is 15 degrees dorsiflexion, 40 degrees plantarflexion.Her strength is 5/5 in all 4 planes of motion.Overall, she notes moderately good pain relief compared to her preoperative state.No fevers or chills.No new incidents.Xrays show lucencies under the tibial tray and a new fractured tibial tray peg, which was not present before.It is concerning for tibial component loosening.Her pain levels are still improved compared to before her operation, and her tibial tray lucencies are otherwise unchanged.She does not want to do anything as her pain levels are relatively low and her function is good.Therefore, i recommended that we proceed with clinical monitoring with periodic x-rays every 6 months instead of every 12 months.The alternative would be to proceed with work-up for sources of loosening, but as her symptoms are manageable, i recommended that we will hold off on this.She agrees to this plan.Follow up: 6 months.
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 not be confirmed since the device was not returned for evaluation and no other evidence 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
Subject: (b)(6).Infinity with adaptis (itar2) study.Adverse event: implant failure result date: (b)(6) 2025.There is an infinity total ankle with a previous calcaneal osteotomy.The talar component is well-fixated and unchanged compared to previous images.However, the tibial component has a fractured posterior peg that was not present on x-rays taken 1 year ago.There are also lucencies about the tibial tray which were present previously.This suggests a loose tibial tray.Multiple previous x-rays, including index imaging, are today reviewed and compared to current imaging to discern bony healing, changes in alignment, and overall radiographic status.This review and comparison are intrinsic to today's evaluation and decision making.Assessment the patient is a nice 64 y.O., female with right ankle pain.Diagnosis: ~3 years s/p right tar (dos: (b)(6) 2022) data reviewed: today's xrays and previous sets of xrays.The applicable imaging was reviewed with the patient.Discussion/plan: the patient presents today for her 3-year follow up of her right ankle replacement.She notes occasional achy pain as well as bruising in the lateral ankle.On physical examination, ankle motion is 15 degrees dorsiflexion, 40 degrees plantarflexion.Her strength is 5/5 in all 4 planes of motion.Overall, she notes moderately good pain relief compared to her preoperative state.No fevers or chills.No new incidents.Xrays show lucencies under the tibial tray and a new fractured tibial tray peg, which was not present before.It is concerning for tibial component loosening.Her pain levels are still improved compared to before her operation, and her tibial tray lucencies are otherwise unchanged.She does not want to do anything as her pain levels are relatively low and her function is good.Therefore, i recommended that we proceed with clinical monitoring with periodic x-rays every 6 months instead of every 12 months.The alternative would be to proceed with work-up for sources of loosening, but as her symptoms are manageable, i recommended that we will hold off on this.She agrees to this plan.Follow up: 6 months.

• Brand Name: INFINITY ADAPTIS TIB SZ4LNG 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23355508
• Report Number: 3010667733-2025-01210
• Device Sequence Number: 8965410
• Product Code: HSN
• UDI-Device Identifier: 00889797069694
• UDI-Public: (01)00889797069694(11)211104(17)291102(10)1718061
• Combination Product (Y/N): N
• 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): 12/16/2025

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: 33680014
• Device Lot Number: 1718061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2021
• 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: Other
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 64 KG