MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	350-21-23
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994); Osteopenia/ Osteoporosis (2651); Implant Pain (4561)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported post-op via clinical study that the 62 yo female patient was experiencing off and on pain, received ct scan.Ct scan found large cyst on posterior lateral aspect of tibia and smaller one under anterior lateral aspect of talus.The date of adverse event onset is 01/18/2023.The plan is to treat with bone graft of cyst and appointment to be scheduled.The patient¿s outcome was last known as, continuing.The case report form indicates this event is possibly related to devices and procedure.
Additional Manufacturer Narrative
Concomitants: serial #: (b)(4) category #: 350-11-04 - tibial plate fb sz 4 lt, serial #: (b)(4) category #: 350-01-03 - talar implant sz 3 lt, serial #: (b)(4) category #: 350-10-04 - ankle sz 4 locking clip,.
Event or Problem Description
As reported post-op via clinical study that the 62 year old female patient was experiencing off and on pain, received ct scan.Ct scan found large cyst on posterior lateral aspect of tibia and smaller one under anterior lateral aspect of talus.The date of adverse event onset is (b)(6) 2023.The plan is to treat with bone graft of cyst and appointment to be scheduled.The patient¿s outcome was last known as, continuing.The case report form indicates this event is possibly related to devices and procedure.The outcome of this event is resolved through surgical revision on (b)(6) 2023.
Additional Manufacturer Narrative
H3: additional information in b4.Upon review of the available information, there is no evidence that this is a device related problem and no allegation against the device.Implantation of a total joint could result pain, infection, loosening of total joint hardware and the patient should monitor their activity and stresses to the operated ankle.The most likely cause of the reported event is the patient¿s conditions.
Additional Manufacturer Narrative
Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the patient's condition cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
H6: corrected health effect and medical device codes.

• Brand Name: VANTAGE
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16550775
• Report Number: 1038671-2023-00447
• Device Sequence Number: 14161705
• Product Code: HSN
• UDI-Device Identifier: 10885862276315
• UDI-Public: 10885862276315
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/18/2024

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 Expiration Date: 10/12/2024
• Device Catalogue Number: 350-21-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 11/29/2023; 11/29/2023; Not provided
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 11/30/2023; 03/05/2024; 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White