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

Model Number	350-12-04
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The revision reported was likely the result of an insufficient bond between the implant and the bone, which led to aseptic (non-infected) tibial loosening.However, this cannot be confirmed as the devices were not available for evaluation.Concomitant device(s): 350-02-04, 4755507 - talar implant sz 4 rt, 350-10-04, 5132321 - ankle sz 4 locking clip, 350-22-64, 4588357 - tibial insert fb sz 4 rt 12mm.
Event or Problem Description
Approximately 1.5 years postop the initial ankle implant, this male patient experienced tibial loosening and was revised.Patient is doing well now.Removal of vantage implant.No other information available as revision was completed out of the clinical study and no study id was available.Device is not returning.

• Brand Name: VANTAGE
• Common Device Name: TIBIAL PLATE FB SZ 4 RT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11330180
• Report Number: 1038671-2021-00046
• Device Sequence Number: 16377483
• Product Code: HSN
• UDI-Device Identifier: 10885862276209
• UDI-Public: 10885862276209
• 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: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/15/2021

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: 350-12-04
• Device Catalogue Number: 350-12-04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2021
• Initial Report FDA Received Date: 02/15/2021
• 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