MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL INSERT FB SZ 1 RT 7MM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	350-22-11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930); Pain (1994)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 350-12-01 - tibial plate fb sz 1 rt 350-02-01 - talar implant sz 1 rt (h3) pending evaluation.
Event or Problem Description
As reported by the exactech vantage total ankle study, the 43-year-old female patient had a right taa on (b)(6) 2018/ and presented with infection and pain.On (b)(6) 2018 patient presented with superficial skin infection and delayed wound healing that was treated with medication and resolved on (b)(6) 2018.On (b)(6) 2018, patient underwent procedure, ankle debridement for medial gutter impingement and neuroplasty of sural nerve due to pain/nerve entrapment, marked as resolved on (b)(6) 2018.Following on (b)(6) 2019 the patient was revised for ongoing infection and pain, plus the other aes.Marked as resolved on (b)(6) 2019.The outcome of this event is considered resolved by revision on (b)(6) 2019.The case report form indicates that this event is definitely related to the device and possibly related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected/ additional information.The following sections were corrected/added: b1, b2, b5, d4, g1, h4, h6: clinical code, component code, type of investigation, investigation findings and investigation conclusions.The reason for the reported revision due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition and/or the previous surgical procedures.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
As reported by the exactech vantage total ankle study, the female patient had a right taa and presented with infection and pain.The patient presented with superficial skin infection and delayed wound healing that was treated with medication and resolved.A few months later, the patient underwent another procedure, ankle debridement for medial gutter impingement and neuroplasty of sural nerve due to pain/nerve entrapment, marked as resolved.Later, the patient was revised for ongoing infection and pain, plus the other aes.Marked as resolved.

• Brand Name: TIBIAL INSERT FB SZ 1 RT 7MM
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18833762
• Report Number: 1038671-2024-00390
• Device Sequence Number: 7181377
• Product Code: HSN
• UDI-Device Identifier: 10885862276377
• UDI-Public: 10885862276377
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K152217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/13/2024
• Device Catalogue Number: 350-22-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2016
• 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: Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: White