MAUDE Adverse Event Report: EXACTECH, INC. TALAR IMPLANT SZ 2 LT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED

Catalog Number	350-01-02
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Osteolysis (2377); Implant Pain (4561)
Date of Event	04/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10.Concomitants: (b)(6), 350-10-04 - ankle sz 4 locking clip; (b)(6), 350-11-04 - tibial plate fb sz 4 lt; (b)(6), 350-21-12 - tibial insert fb sz 2 lt 7mm; ***serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.(b)(6), 351-90-20 - tubercle pin pouch; (b)(6), 351-90-21 - 3.5" pin pouch; (b)(6), 351-90-22 - 2.5" pin pouch.
Event or Problem Description
It was reported via clinical study, that approximately 3 years postop the initial implant, this 69 yo male patient had increasing discomfort and pain located over the subtalar joint, ankle joint, and anteromedial distal tibia.Pain is so severe that patient uses boot to ambulate.Imaging demonstrates flattening of the talar dome and mild subsidence of the talar hardware and multifocal periprosthetic osteolysis along the tibial hardware-bone interface measuring up to 2.1 cm.Patient was revised to left ankle arthroplasty with inbone-ii prosthesis.The patient¿s outcome was last known as resolved.Devices will not be returned.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, g3, h6, h11.Mdr section codes updated/corrected: a, b, c, d, e, g.The reason for the revision cannot be confirmed from the information provided but may be the result of a combination of patient-related conditions that may have contributed to talar subsidence.Potential contributions of user-related considerations to the event could not be assessed as the devices were not available for evaluation and images and 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 2 LT
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: geoff gannon
• MDR Report Key: 17484818
• Report Number: 1038671-2023-01912
• Device Sequence Number: 7821591
• Product Code: HSN
• UDI-Device Identifier: 10885862276704
• UDI-Public: 10885862276704
• 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: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2025

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: 350-01-02
• 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: 09/24/2025
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Race: White