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
The loosening reported was likely the result of either an insufficient bond between the implant and the bone, patient-related conditions related to medical history and/or previous operations on involved ankle, or a combination of the two.However, this cannot be confirmed as the patient has not yet been revised; therefore, the devices were not available for evaluation.Concomitant device(s): 350-22-62, tibial insert fb sz 2 rt 12mm, 350-02-01, talar implant sz 1 rt.
Event or Problem Description
As reported, the (b)(6) male patient presented with pain "like before my surgery" after beginning a walking program.Patient¿s bmi is (b)(6), weight is (b)(6).X-rays show cyst formation and early loosening in right ankle.The patient was instructed to reduce walking and return in 2 months.Patient has a history of post traumatic arthritis, hypertension, a-fib; pad; h/o pulmonary embolism & skin cancer.The case report form indicates this event is possibly related to devices or procedure.This event report was received through clinical data collection activities.

• 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: 11086722
• Report Number: 1038671-2020-00670
• Device Sequence Number: 11475450
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/29/2020

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: 350-12-03
• Device Catalogue Number: 350-12-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 12/29/2020
• 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: 70 YR
• Patient Weight: 109