MAUDE Adverse Event Report: EXACTECH, INC. TALAR IMPLANT SZ 4 RT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	350-02-04
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Pain (1994); Implant Pain (4561)
Date of Event	01/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the exactech vantage total ankle study, the 68-year-old caucasian male patient had a right taa on (b)(6) 2018.On (b)(6) 2023, patient presented with pain that had been ongoing 4-5 months.He reported increased anteromedial and lateral pain that is worse with increased activity and weightbearing.Ct findings determined there were large cystic lucencies underlie the talar plate component measuring up to 2.3 cm.The patient underwent revision surgery on (b)(6) 2023 and the outcome of this event is considered to be resolved.The case report form indicates that this event is definitely not related to the device and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
(d10) concomitant device(s): 350-02-04 - talar implant sz 4 rt : (b)(6).350-10-04 - ankle sz 4 locking clip : (b)(6).350-22-04 - tibial insert fb sz 4 rt 6mm : (b)(6).351-91-03 - recip sawblade 8x50x1mm : (b)(6).(h3) pending evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, d4, g4, h4, h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The cause of the patient¿s bone cysts and revision reported cannot be conclusively determined; however, it may be due to patient-related factors, a reaction to wear or debris particles, or component alignment.However, the failure could not be confirmed because the devices were not returned for evaluation, and relevant patient information, images, or radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TALAR IMPLANT SZ 4 RT
• 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: matt collins ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19076503
• Report Number: 1038671-2024-00773
• Device Sequence Number: 14960059
• Product Code: HSN
• UDI-Device Identifier: 10885862276766
• UDI-Public: 10885862276766
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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: Health Professional
• Device Catalogue Number: 350-02-04
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Race: White