MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY POLY SZ 4 6MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33654406
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted in the patient and therefore is not available for return for device evaluation.When additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient had medial gutter pain in the right ankle.The patient had tenderness in the front of the ankle joint.No signs of redness or heat noted.Bloods taken & referred for ultrasound-guided aspiration to rule out infection.Unable to aspirate any fluid.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation.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.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.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.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the patient had medial gutter pain in the right ankle.The patient had tenderness in the front of the ankle joint.No signs of redness or heat noted.Bloods taken & referred for ultrasound-guided aspiration to rule out infection.Unable to aspirate any fluid.

• Brand Name: INFINITY POLY SZ 4 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: 19513238
• Report Number: 3010667733-2024-00362
• Device Sequence Number: 20566067
• Product Code: HSN
• UDI-Device Identifier: 00840420122780
• UDI-Public: 00840420122780
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

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 Expiration Date: 07/03/2025
• Device Catalogue Number: 33654406
• Device Lot Number: 1600488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2017
• 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: Other
• Patient Sex: Male
• Patient Weight: 89 KG