MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL PLATE FB SZ 1 LT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 350-11-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Osteolysis (2377)

Event Date 11/09/2023

Event Type  Injury  

Event Description

As reported by the exactech vantage total ankle study, the 62 year old female patient had an initial left taa on (b)(6) 2022 and presented with lucency and cyst formation approximately 1 year post initial procedure on (b)(6) 2023.On (b)(6) 2023, the subject's radiographic findings determined there is increased lucency about the tibial component compared to (b)(6) 2023.Subject came in for a follow-up visit pertaining to the findings on (b)(6) 2024.On (b)(6) 2024, radiographic findings stated that there was stable lucency about the tibial component compared to (b)(6) 2023, but increased since (b)(6) 2023.The case report form indicates that this event is unlikely related to the device and definitely not related to the procedure.The report also indicates the action taken was medication and the outcome of this event is continuing.350-11-01 - tibial plate fb sz 1 lt: 6694220.No device return anticipated due to being a clinical trial study.

Manufacturer Narrative

(d10) concomitant device(s): 350-21-21 - tibial insert fb sz 1 lt 8mm: 5299361, 350-10-01 - ankle sz 1 locking clip: 7041185, 350-01-01 - talar implant sz 1 lt 6860302, 351-91-03 - recip sawblade 8x50x1mm: 038799.

• Brand Name: TIBIAL PLATE FB SZ 1 LT
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18620233
• MDR Text Key: 334258641
• Report Number: 1038671-2024-00144
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 10885862276131
• UDI-Public: 10885862276131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 350-11-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Race: White