MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ4 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680004
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Implant Pain (4561)
Date of Event	07/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "subject: (b)(6).Infinity¿ with adaptis¿ total ankle replacement follow-up (itar2).Aseptic loosening: subject reported gradual worsening pain in the study ankle.[the surgeon's] pa noted that the pain seemed "somewhat migratory around the anterior ankle, medial and lateral hindfoot even up into the lower leg with some tenderness medially along tibia." pa did not note any subsidence of hardware on x-rays.Subject received fluoroscopic guided right subtalar joint injection as treatment.(b)(6) 2023: worsening.Loosening of tibial component noted on x-rays.(b)(6) 2023: no change.No progression of loosening.Pi attributed ankle pain to loosening at this visit.(b)(6) 2024: pain was resolved and x-rays showed no further progression.Resolved without sequelae.".
Additional Manufacturer Narrative
The device is not available for evaluation as it remains implanted in the patient.Once the investigation has been completed any additional information will be reported 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
As reported: "subject: (b)(6) infinity¿ with adaptis¿ total ankle replacement follow-up (itar2) aseptic loosening: subject reported gradual worsening pain in the study ankle.[the surgeon's] pa noted that the pain seemed "somewhat migratory around the anterior ankle, medial and lateral hindfoot even up into the lower leg with some tenderness medially along tibia." pa did not note any subsidence of hardware on x-rays.Subject received fluoroscopic guided right subtalar joint injection as treatment.(b)(6)2023: worsening.Loosening of tibial component noted on x-rays (b)(6) 2023: no change.No progression of loosening.Pi attributed ankle pain to loosening at this visit.(b)(6) 2024: pain was resolved and x-rays showed no further progression.Resolved without sequelae.".

• Brand Name: INFINITY ADAPTIS TIB SZ4 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21468381
• Report Number: 3010667733-2025-00205
• Device Sequence Number: 3391330
• Product Code: HSN
• UDI-Device Identifier: 00889797069663
• UDI-Public: 00889797069663
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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: 33680004
• Device Lot Number: 1697267
• 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: 01/29/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2020
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 86 KG