MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL INSERT FB SZ 2 RT 6MM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	350-22-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthralgia (2355); Ankylosis (4527)
Date of Event	05/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a poly exchange and a surgical procedure for ankylosis that was causing pain approximately 3 years 7 months after implant.Revision operative report of (b)(6) 2023- right ankle replacement with polyethylene exchange/right achilles lengthening.Work-up showed no loosening of the implant but rather significant bone formation particularly on the lateral gutter which ankylosed the distal fibula to the talus, no infection.Surgeon explained that they might not be able to obtain normal motion but would help with pain.Substantial scarring at the front of ankle.The lateral and medial gutter was completely bridged with bone.The patient was taken to recovery in stable condition.There is no other information available.
Additional Manufacturer Narrative
H3.Investigation results-there is no indication from the operative report that there was a device malfunction, the patient had the distal fibula ankylose to the talus.The cause of the patient¿s pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.There is no additional information available.

• Brand Name: TIBIAL INSERT FB SZ 2 RT 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 INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 19451793
• Report Number: 1038671-2024-01683
• Device Sequence Number: 18295573
• Product Code: HSN
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: 350-22-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2019
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female