MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY POLY SZ 3+ 7MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33654307
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Arthritis (1723); Cyst(s) (1800); Post Operative Wound Infection (2446); Inadequate Osseointegration (2646)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery.The primary implant consisted of a tibial tray and talar dome.The patient later required removal of the implant and placement of an antibiotic cement spacer due to suspected infection, along with noted poor bone quality and a large bone cyst superior to the tibial tray.
Additional Manufacturer Narrative
Additional information has been requested and, if received, will be provided in the supplemental report.
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery.The primary implant consisted of a tibial tray and talar dome.The patient later required removal of the implant and placement of an antibiotic cement spacer due to suspected infection, along with noted poor bone quality and a large bone cyst superior to the tibial tray.
Additional Manufacturer Narrative
The complaint was confirmed, since the information for evaluation matches the alleged failure.Upon further investigation of the ct scans by healthcare professionals the following was observed: the ct scan shows a girdlestone situation with a cement spacer at the former ankle joint.The initial operation was performed in 2016, infection was suspected, although not confirmed by biological findings.There is the large cysts visible adjacent to the cement which have been reported and the poor bone status can be confirmed.The date of implantation is approx.9 years ago and therefore a direct link to either the device or the implantation cannot be made.The failure is therefore not to be assessed as being linked to this.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.More detailed information about the complaint event 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.

• Brand Name: INFINITY POLY SZ 3+ 7MM 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: 23528283
• Report Number: 3010667733-2025-01321
• Device Sequence Number: 9140768
• Product Code: HSN
• UDI-Device Identifier: 00840420122742
• UDI-Public: 00840420122742
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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: 33654307
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown