MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; TIBIAL INSERT FB SZ 3 LT 6MM

Model Number	350-21-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the bone formation and subsequent surgery cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.Concomitant device(s): 350-11-04, tibial plate fb sz 4 lt.350-01-03, talar implant sz 3 lt.
Event or Problem Description
As reported, this (b)(6) y/o male patient developed heterotrophic bone at the medial malleolus.Surgical excision of heterotrophic bone at the medial malleolus, and debridement of ankle joint.The patient has history of osteoarthritis, hypertension, uses tobacco.The case report form indicates this event is not related to devices or procedure.This event report was received through clinical data collection activities.

• Brand Name: VANTAGE
• Common Device Name: TIBIAL INSERT FB SZ 3 LT 6MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10497940
• Report Number: 1038671-2020-00511
• Device Sequence Number: 14187569
• Product Code: HSN
• UDI-Device Identifier: 10885862276230
• UDI-Public: 10885862276230
• Combination Product (Y/N): N
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

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 Model Number: 350-21-03
• Device Catalogue Number: 350-21-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 09/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 93