MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL INSERT FB SZ 1 LT 6MM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	350-21-01
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 350-01-01 - talar implant sz 1 lt: (b)(6).350-10-02 - ankle sz 2 locking clip: (b)(6).350-11-02 - tibial plate fb sz 2 lt: (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: (b)(6).351-90-24 - talar trial screw pouch: (b)(6).351-91-03 - recip sawblade 8x50x1mm: 289020.351-91-04 - saw-10x75x1.19-stryker: 001568.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
The patient previously underwent a left total ankle arthroplasty.The patient later presented to the surgeon¿s office with pain and poly wear.Patient was last known to be in stable condition following the event.No further information is available.

• Brand Name: TIBIAL INSERT FB SZ 1 LT 6MM
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24547012
• Report Number: 1038671-2026-00242
• Device Sequence Number: 12193818
• Product Code: HSN
• UDI-Device Identifier: 10885862276216
• UDI-Public: 10885862276216
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K152217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

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 Catalogue Number: 350-21-01
• 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: 02/18/2026
• Initial Report FDA Received Date: 03/09/2026
• Date Device Manufactured: 01/21/2020
• 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 H11.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 34 YR
• Patient Sex: Female