MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY EVERLAST SZ 3 6MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33683306
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Swelling/ Edema (4577)
Date of Event	08/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "subject: (b)(6) infinity¿ with adaptis¿ technology total ankle replacement follow-up (itar2).On (b)(6) 2022: surgical intervention.Multiple injuries to study ankle requiring surgical intervention.Partial excision of fibula for osteomyelitis transfer of adjacent tissue.This event is captured under stryker reference#'s: (b)(4).Update on (b)(6) 2022: no change.Sutures remain; dry dressing applied.Walking boot continued.Weight-bear for tolerated in the walking boot.Update on (b)(6) 2022: worsening.Patients entire ankle joint is infected subsequent from seeding posterolateral.Patient noted swelling and chills.Will do cultures implant removal irrigation debridement, antibiotic spacer, and admission with iv antibiotics.Update on (b)(6) 2022: surgical intervention due to deep infection.Reoperation with removal of tibial and/or talar implanted components.This event is captured this record.".
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.
Additional Manufacturer Narrative
The reported event could be confirmed based on the operative notes and the administration of antibiotics to the patient.A microbiologist 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 deviations or non-conformances could be found.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)(4) infinity¿ with adaptis¿ technology total ankle replacement follow-up (itar2).25 aug 2022: surgical intervention.Multiple injuries to study ankle requiring surgical intervention.Partial excision of fibula for osteomyelitis transfer of adjacent tissue.This event is captured under stryker reference #'s (b)(4).Update 01 sep 2022: no change.Sutures remain, dry dressing applied.Walking boot continued.Weight-bear for tolerated in the walking boot.Update 05 oct 2022: worsening.Patients entire ankle joint is infected subsequent from seeding posterolateral.Patient noted swelling and chills.Will do cultures implant removal irrigation debridement, antibiotic spacer, and admission with iv antibiotics.Update 11 oct 2022: surgical intervention due to deep infection.Reoperation with removal of tibial and/or talar implanted components.This event is captured this record.".

• Brand Name: INFINITY EVERLAST SZ 3 6MM 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; 1023 cherry rd; memphis TN 38117
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21572308
• Report Number: 3010667733-2025-00322
• Device Sequence Number: 8940867
• Product Code: HSN
• UDI-Device Identifier: 00889797074513
• UDI-Public: (01)00889797074513(11)200205(17)280203(10)1677392
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193067
• 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): 05/21/2025

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: 33683306
• Device Lot Number: 1677392
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2020
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 86 KG