MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE TIBIAL INSERT FB SZ 4 RT 12MM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	350-22-64
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Cyst(s) (1800); Discomfort (2330); Joint Laxity (4526)
Date of Event	08/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant devices: 350-12-04 - tibial plate fb sz 4 rt: (b)(6).350-02-04 - talar implant sz 4 rt: (b)(6).350-10-04 - ankle sz 4 locking clip: (b)(6).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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent an initial total ankle replacement on the right side.Subsequently, the patient experienced a cyst formation, frequent inversion events due to persistent ankle instability and discomfort while ambulating.Enlarging cyst formation under tibia tray leading to potential subsidence.As a result, approximately 6 years after initial replacement, the patient underwent a right ankle revision.No further impact to the patient was reported.No other information is available.

• Brand Name: VANTAGE TIBIAL INSERT FB SZ 4 RT 12MM
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21901994
• Report Number: 1038671-2025-01887
• Device Sequence Number: 18341623
• Product Code: HSN
• UDI-Device Identifier: 10885862293442
• UDI-Public: 10885862293442
• 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: 2019
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/24/2025

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 Expiration Date: 12/13/2025
• Device Catalogue Number: 350-22-64
• 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: 04/03/2025
• Initial Report FDA Received Date: 04/24/2025
• Date Device Manufactured: 12/13/2017
• 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 H11.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Race: White