MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; TIBIAL PLATE FB SZ 4 LT

Catalog Number 350-11-04

Device Problems Loose or Intermittent Connection (1371); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); No Information (3190)

Event Date 12/17/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2018.Concern for possible tibial component loosening noted at 6 month post-op visit.The case report form indicates this event is definitely related to devices and definitely related to procedure.This event report was received through clinical data collection activities.

Manufacturer Narrative

Section h10: (a1) patient identifier: (b)(6).(a2) age at the time of event: 62 years.(b2) added check for hospitalization - initial or prolonged.(d4) serial number: (b)(6), expiration date: 09-feb-2028, unique identifier (udi) #: (b)(4).(g5) pma/510(k)number: k152217.(h3) the potential loosening reported was likely the result of an insufficient bond between the implant and the bone, which may have led to aseptic (non-infected) loosening of the tibial component.However, this cannot be confirmed because the component was not available for evaluation.(h4) device manufacture date: 12-feb-2018.Section h11: the following sections have corrected information: (e3) health professional?: should of stated yes.(g3) report source: should of been health professional on initial report.No information provided in the following section(s): b6, b7, d7, d11, g8, h7, h9.

• Brand Name: VANTAGE
• Type of Device: TIBIAL PLATE FB SZ 4 LT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8449368
• MDR Text Key: 139750288
• Report Number: 1038671-2019-00178
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: K152217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 350-11-04
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 90