MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL INSERT FB SZ 1 RT 7MM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 350-22-11

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

Patient Problem Bacterial Infection (1735)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

(d10) concomitant device(s): 350-12-01 - tibial plate fb sz 1 rt 350-02-01 - talar implant sz 1 rt (h3) pending evaluation.

Event Description

As reported by the exactech vantage total ankle study, the 43-year-old female patient had a right taa on (b)(6) 2018/ and presented with infection and pain.On (b)(6) 2018 patient presented with superficial skin infection and delayed wound healing that was treated with medication and resolved on (b)(6) 2018.On (b)(6) 2018, patient underwent procedure, ankle debridement for medial gutter impingement and neuroplasty of sural nerve due to pain/nerve entrapment, marked as resolved on (b)(6) 2018.Following on (b)(6) 2019 the patient was revised for ongoing infection and pain, plus the other aes.Marked as resolved on (b)(6) 2019.The outcome of this event is considered resolved by revision on (b)(6) 2019.The case report form indicates that this event is definitely related to the device and possibly related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.

• Brand Name: TIBIAL INSERT FB SZ 1 RT 7MM
• 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: 18833762
• MDR Text Key: 336858294
• Report Number: 1038671-2024-00390
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 10885862276377
• UDI-Public: 10885862276377
• 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: 03/04/2024

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: 350-22-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: SEE H10.
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: White