MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL PLATE FB SZ 4 LT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	350-11-04
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	06/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical study, that the 63 yo female patient consistently had pain from the time since the first surgery.Patient continues to have pain in dorsum of foot and an inability to ambulate well secondary to the pain.The date of onset is 06-09-2020.The patient underwent revision surgery on (b)(6) 2020.The patient¿s outcome was last known as resolved.
Additional Manufacturer Narrative
Concomitant medical products: serial #: (b)(4), category #: 350-01-02 - talar implant sz 2 lt.Serial #: (b)(4), category #: 350-21-12 - tibial insert fb sz 2 lt 7mm.Serial #: (b)(4), category #: 350-10-04 - ankle sz 4 locking clip.
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the patient's condition cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d1, h6, h11.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.The reason for the clinical symptom of pain reported cannot be conclusively determined and the event cannot be confirmed because the devices were not returned for evaluation, and relevant patient information, 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: TIBIAL PLATE FB SZ 4 LT
• 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, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16553183
• Report Number: 1038671-2023-00448
• Device Sequence Number: 19575666
• Product Code: HSN
• UDI-Device Identifier: 10885862276162
• UDI-Public: 10885862276162
• 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: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 350-11-04
• 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: 02/17/2023
• Supplement Date Received by Manufacturer: 06/29/2023; 02/06/2026
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 09/28/2023; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American