MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL PLATE FB SZ 4 LT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number TIBIAL PLATE FB SZ 4 LT

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

Patient Problem Implant Pain (4561)

Event Date 06/16/2023

Event Type  Injury  

Event Description

As reported by the exactech vantage total ankle study, approximately 2.5 years post initial left taa, the 72 y/o male patient returned for pain below taa.The surgeon determined there is irregularity in the subtalar joint.Patient was given injection steroid into subtalar joint.Then, on (b)(6) 2023, follow-up from his sinus tarsi injection on the left ankle.The patient states that he did not get any relief even temporarily with the shot.The patient is mostly tender over the posterior tibial tendon.Referral to another surgeon for consideration of opening debridement and fdl tendon transfer.On (b)(6) 2023, the patient was there for follow-up.Patient has tried pt/hep.Pain worsening.Isolated to the posteromedial ankle.Has left posterior tibial tendinitis/partial tearing in the setting of prior taa.The event was resolved with patient having a revision on (b)(6) 2024.Per clinical report, the reported event is definitely not related to the device but possibly related to the procedure.

Manufacturer Narrative

Section d10: concomitant products: tibial insert fb sz 2 lt 12mm (cat# 350-21-62 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: TIBIAL PLATE FB SZ 4 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: michael crader
• MDR Report Key: 18990537
• MDR Text Key: 338797743
• Report Number: 1038671-2024-00684
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 10885862276162
• UDI-Public: 10885862276162
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TIBIAL PLATE FB SZ 4 LT
• Device Catalogue Number: 350-11-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/24/2020
• 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
• Treatment: ANKLE SZ 4 LOCKING CLIP; TALAR IMPLANT SZ 2 LT
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White