MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE ANKLE COMPONENTS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	TIBIAL PLATE FB SZ 2 LT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Pain (1994)
Date of Event	08/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant products: 350-01-02 - talar implant sz 2 lt 5186556, 350-10-02 - ankle sz 2 locking clip 5125244, 350-21-02 - tibial insert fb sz 2 lt 6mm 4536664, 351-91-03 - recip sawblade 8x50x1mm 215204.
Event or Problem Description
As reported, the patient had an initial ankle replacement on (b)(6) 2018.Approximately (b)(6) 2021 the patient developed a cystic formation on the tibial and talar side.The components are not loose and no failure of implant detected.Alignment is well maintained, but pain persists and it is difficult to walk.The patient was revised on (b)(6) 2022.
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 issues.The cause of surgical revision for pain cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.H7: z-0024-2022.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b3 (correcting date from initial report), d1, d4 (remove all from initial report-suspect device unknown), d8, g4 (remove from initial report-501k unknown), h6: component codes, impact code, component code, investigation findings and investigation conclusion.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: VANTAGE ANKLE COMPONENTS
• 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 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15414813
• Report Number: 1038671-2022-01106
• Device Sequence Number: 2556545
• Product Code: HSN
• UDI-Device Identifier: 10885862276148
• UDI-Public: 10885862276148
• 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: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TIBIAL PLATE FB SZ 2 LT
• Device Catalogue Number: 350-11-02
• 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: 08/24/2022
• Supplement Date Received by Manufacturer: 10/11/2022; 10/27/2025
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 10/29/2022; 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2017
• 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: Hospitalization; Required Intervention; Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White