MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; TIBIAL PLATE FB SZ 4 LT

Catalog Number	350-11-04
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event report was received through clinical data collection activities.Pending evaluation.Concomitant devices: liner (cn: 350-21-14; sn: not reported).Talar (cn: 350-01-04; sn: not reported).
Event or Problem Description
Index surgery: (b)(6) 2019.Sometime during the initial 3 month post-op period the patient developed an infection in his ankle.The vantage implant was removed by an outside surgeon at the (b)(6) clinic in (b)(6) (closer to patient's home) in (b)(6) 2019.The exact date is unknown.The case report form indicates this event is definitely not related to devices and definitely related to procedure.
Additional Manufacturer Narrative
The revision reported was likely the result of infection.However, this cannot be confirmed as no further information was provided.The sterile records were reviewed for all components, and all parts were sterilized to the appropriate doses.Superficial and deep infection are listed under general surgical risks in the vantage fixed bearing ifu (700-096-157).

• Brand Name: VANTAGE
• Common Device Name: TIBIAL PLATE FB SZ 4 LT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8658896
• Report Number: 1038671-2019-00310
• Device Sequence Number: 14028180
• Product Code: HSN
• UDI-Device Identifier: 10885862276162
• UDI-Public: 10885862276162
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

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: 350-11-04
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/08/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 106