MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ5 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415); Joint Impingement (4834)
Date of Event	05/17/2023
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) infinity with adaptis (itar2) study.(b)(6) 2023 narrative of adverse event: the patient is a 64 y.O.Year old male who is here for follow up of left tar.He reports continued paresthesias at the dorsal forefoot and pain at the medial ankle.His pain is overall better compared to pre-surgery.On pe, ankle motion is 10 degrees dorsiflexion, 40 degrees plantarflexion.X-rays show the total ankle prosthesis appears stable, no evidence of loosening, fractures, and in acceptable alignment.There appears to be bony impingement at the tip of the medial malleolus w/ the talus.I suspect that his pain is due to medial ankle impingement.Our next step would be to either have him undergo a diagnostic injection of numbing medicine into the medial ankle versus sending him for a spect scan.He elects to proceed w/ the diagnostic injection.He was advised to be very active during the next 24 hours and work on ankle pumps to determine the level of relief from the injection.Future operative treatment would consist of a medial ankle gutter debridement if the injection were to provide relief.Injection: left ankle joint.After informed consent was obtained, the injection site was prepped with betadine and alcohol.Then a solutions each containing 3 ml of 0.25% marcaine kenalog and 3 ml of 1% lidocaine were infused about the medial gutter.Sterile needles and two 3-ml syringes were used.Hemostasis was obtained and a band-aid was applied.The patient was counseled to expect immediate pain relief and then a period of soreness until the steroid takes effect.
Additional Manufacturer Narrative
The reported event not be confirmed since the device was not returned for evaluation and no other evidence were provided.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.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 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.(b)(6) 2023: narrative of adverse event: the patient is a 64 y.O.Year old male who is here for follow up of left tar.He reports continued paresthesias at the dorsal forefoot and pain at the medial ankle.His pain is overall better compared to pre-surgery.On pe, ankle motion is 10 degrees dorsiflexion, 40 degrees plantarflexion.X-rays show the total ankle prosthesis appears stable, no evidence of loosening, fractures, and in acceptable alignment.There appears to be bony impingement at the tip of the medial malleolus w/ the talus.I suspect that his pain is due to medial ankle impingement.Our next step would be to either have him undergo a diagnostic injection of numbing medicine into the medial ankle versus sending him for a spect scan.He elects to proceed w/ the diagnostic injection.He was advised to be very active during the next 24 hours and work on ankle pumps to determine the level of relief from the injection.Future operative treatment would consist of a medial ankle gutter debridement if the injection were to provide relief.Injection: left ankle joint - after informed consent was obtained, the injection site was prepped with betadine and alcohol.Then a solutions each containing 3 ml of 0.25% marcaine kenalog and 3 ml of 1% lidocaine were infused about the medial gutter.Sterile needles and two 3-ml syringes were used.Hemostasis was obtained and a band-aid was applied.The patient was counseled to expect immediate pain relief and then a period of soreness until the steroid takes effect.

• Brand Name: INFINITY ADAPTIS TIB SZ5 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: 23355586
• Report Number: 3010667733-2025-01211
• Device Sequence Number: 21048726
• Product Code: HSN
• UDI-Device Identifier: 00889797069670
• UDI-Public: (01)00889797069670(11)210303(17)290301(10)1702976
• 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: 33680005
• Device Lot Number: 1702976
• 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: 09/26/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• 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: 03/03/2021
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 93 KG