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	12/11/2020
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, patient-related conditions, or a combination of the two, which led to aseptic (non-infected) tibial loosening.However, this cannot be confirmed as the devices were not available for evaluation.Concomitant device(s): 350-22-42, 4537611 - tibial insert fb sz 2 rt 10mm, 350-02-02, 5700605 - talar implant sz 2 rt, 351-91-03, 289020 - recip sawblade 8x50x1mm, 350-10-04, 5627016 - ankle sz 4 locking clip.
Event or Problem Description
Approximately 2 years postop the initial right ankle implant, this (b)(6) y/o male patient experienced tibial loosening and was revised.Patient is doing well now.Removal of vantage implant.The patient has a history of non-union of subtalar arthrodesis.No other information available as revision was completed out of the clinical study.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: 11330174
• Report Number: 1038671-2021-00043
• Device Sequence Number: 13686686
• 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: 2018
• Device Explanted Year: 2020
• 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
• Patient Age: 55 YR
• Patient Weight: 91