MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC FLAT CUT TALAR DOME SZ 4 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680034
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	04/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient underwent a device explant surgery due to painful ankle.No gross signs of loosening and infection workup was negative.The patient received a cement spacer.The patient was scheduled to received invision implants on (b)(6) 2026.

• Brand Name: FLAT CUT TALAR DOME SZ 4 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: 25071897
• Report Number: 3010667733-2026-00409
• Device Sequence Number: 18746532
• Product Code: HSN
• UDI-Device Identifier: 00889797073080
• UDI-Public: 00889797073080
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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: 33680034
• Device Lot Number: 1723169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/04/2026
• 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: Male
• Patient Weight: 104 KG