MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY TIBIAL TRAY SZ 4 LNG TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33650014
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Medical device site infection (4845)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported by the customer that the patient required a revision surgery because of a staged revision approach, requiring the implanting a cement spacer due to peritibial cystic loosening with infection.The tibial component demonstrated loosening.With the talar components the morse taper between the talar dome and the talar stem had not been properly engaged and inspection after removal of the talar stem revealed delamination of the plasma coating.
Event or Problem Description
It was reported by the customer that the patient required a revision surgery because of a staged revision approach, requiring the implanting a cement spacer due to peritibial cystic loosening with infection.The tibial component demonstrated loosening.With the talar components the morse taper between the talar dome and the talar stem had not been properly engaged and inspection after removal of the talar stem revealed delamination of the plasma coating.
Additional Manufacturer Narrative
Correction to h3(device evaluated by mfg).The reported event could not be confirmed, indeed the product was returned for evaluation, but it does not matches the alleged failure.During visual inspection of returned device it was observed that there were deep scratch marks present between the pegs, made by hard instrument, by this action the coating got peeled off.Hence, there were signs of delamination of plasma coating and tear of poly component edges after explantation.It is no longer possible to determine whether the coating came off postoperatively or during explantation.Microbiologists reviewed the sterilization procedures, environmental monitoring, bioburden data and the dhr and noted: the subject device was packaged according to established design and process specifications and was sterilized according to procedure.No deviation for a non-conformance could be found.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.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.If more information is provided, the case will be reassessed.

• Brand Name: INFINITY TIBIAL TRAY SZ 4 LNG TOTAL ANKLE SYSTEM
• 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: 23596190
• Report Number: 3010667733-2025-01371
• Device Sequence Number: 10380119
• Product Code: HSN
• UDI-Device Identifier: 00840420122551
• UDI-Public: (01)00840420122551(11)190523(17)270521(10)1653655
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 33650014
• Device Lot Number: 1653655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2019
• 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 Sex: Male