MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; TIBIAL PLATE FB SZ 3 RT

Model Number	350-12-03
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 350-22-62, (b)(4) tibial insert fb sz 2 rt 12mm.350-02-02, (b)(4) talar implant sz 2 rt.350-10-03, (b)(4) ankle sz 3 locking clip.
Event or Problem Description
Approximately 2.5 years postop the initial right ankle implant, this (b)(6) y/o female patient experienced tibial loosening and was revised.Patient has a history of post traumatic arthritis, osteoporosis, and hypertension.Patient is doing well now.Removal of vantage implant.No other information available as revision was completed out of the clinical study.Device is not returning.
Additional Manufacturer Narrative
Section h10: (h3) 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.

• Brand Name: VANTAGE
• Common Device Name: TIBIAL PLATE FB SZ 3 RT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11323996
• Report Number: 1038671-2021-00039
• Device Sequence Number: 3248129
• Product Code: HSN
• UDI-Device Identifier: 10885862276193
• UDI-Public: 10885862276193
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: 350-12-03
• Device Catalogue Number: 350-12-03
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 06/02/2021
• 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: 59 YR
• Patient Weight: 94