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

Model Number	33683306
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930)
Date of Event	03/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
The patient presented from wound care who expressed concern over a worsening wound on his anterior ankle.The patient unfortunately has a non-healing wound over their anterior ankle which probes down to bone.Given the large wound and likely exposed prosthesis, the patient needs to return to or for i&d and poly exchange.
Additional Manufacturer Narrative
Please note the correction made to the g1 manufacturing site for devices: the reported event was confirmed, based on available medical record and health care professionals opinion.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿deep wound infection (early or late) which may necessitate removal of the prosthesis.On rare occasions, arthrodesis of the involved joint or amputation of the limb may be required.¿ formal medical opinion was sought from an experienced independent medical expert as below: there is no reason to believe that in the short timeframe between the primary implantation and in this complication, any loosening could be seen as the implant has not yet integrated in the bone at all.Therefore, a ct scan is not helpful for the further assessment, here.However, the surgeon explained the clinical situation in which the patient presented an early infection of the implant (within 6 weeks after implantation) with severe wound healing and closure issues.The patient was transferred to the op for revision with i&d and exchange of the poly insert.There were no results of the specimen taken presented so far, therefore we only have a clinical suspicion of an infection.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by infection at early stage of surgery.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
The patient presented from wound care who expressed concern over a worsening wound on his anterior ankle.The patient unfortunately has a non-healing wound over their anterior ankle which probes down to bone.Given the large wound and likely exposed prosthesis, the patient needs to return to or for i&d and poly exchange.

• 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.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16765799
• Report Number: 3010667733-2023-00202
• Device Sequence Number: 17654044
• Product Code: HSN
• UDI-Device Identifier: 00889797074513
• UDI-Public: 00889797074513
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K193067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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 Model Number: 33683306
• Device Catalogue Number: 33683306
• Device Lot Number: 1681386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2020
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 99 KG