MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE TIBIAL INSERT FB SZ 2 RT 7MM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	350-22-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cyst(s) (1800)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitants: 350-02-02 - talar implant sz 2 rt : (b)(6), 350-10-03 - ankle sz 3 locking clip : (b)(6), 350-12-03 - tibial plate fb sz 3 rt : (b)(6), 351-91-03 - recip sawblade 8x50x1mm : (b)(6).
Event or Problem Description
Approximately 2 years, 1 month, 22 days post-operative of a right taa, it was reported via clinical study that the patient experienced a cyst formation.X-rays show a new cyst approximately 11 x 9 mm.Following, another surgeon determined surgical intervention was best to resolve this.They decided that removing the poly, debriding the gutters, back filling the bone cyst with bone graft, and then inserting a new poly component.The patient underwent revision surgery with the reported removal of the tibial insert.The outcome of this event is considered resolved and the clinical report indicates that this event is definitely not related to the device and possibly related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
His follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h6, h11.The following sections were corrected: 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.A definitive root cause was unable to be determined; however, may have been due to cyst formation, as stated in the information reported.However, this cannot be confirmed and potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information 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: VANTAGE TIBIAL INSERT FB SZ 2 RT 7MM
• 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 ; 3523771140
• MDR Report Key: 20604462
• Report Number: 1038671-2024-04224
• Device Sequence Number: 15306517
• Product Code: HSN
• UDI-Device Identifier: 10885862276384
• UDI-Public: 10885862276384
• 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: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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 Expiration Date: 12/13/2025
• Device Catalogue Number: 350-22-12
• 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: 04/09/2024
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0024-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Race: White