MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE TALAR IMPLANT SZ 2 RT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	350-02-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported approximately 3 months after a right tsa, the patient experienced post operative neuropathic pain that felt like a crushing or squeezing around the ankle.The patient was prescribed medication and underwent neurology studies to resolve the event and the device remains implanted.It was reported that the event is not related to the device but is related to the procedure.
Additional Manufacturer Narrative
(d10) concomitant device(s): 350-10-03 - ankle sz 3 locking clip 5475350 350-12-03 - tibial plate fb sz 3 rt 5528092 350-22-42 - tibial insert fb sz 2 rt 10mm 5185787 351-91-03 - recip sawblade 8x50x1mm 273914.
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 definitive root cause was unable to be determined; however, 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: VANTAGE TALAR IMPLANT SZ 2 RT
• 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: 19630248
• Report Number: 1038671-2024-02202
• Device Sequence Number: 21001070
• Product Code: HSN
• UDI-Device Identifier: 10885862276742
• UDI-Public: 10885862276742
• 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
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: 350-02-02
• Device Lot Number: 5406988
• 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: 06/06/2024
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• 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
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Race: White