MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; TIBIAL PLATE FB SZ 3 RT

Catalog Number 350-12-03

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

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2018.Radiographs showed increased peri-hardware lucency, consistent with tibial loosening.Patient also reported associated lateral ankle pain.The case report form indicates this event is possibly related to devices and unlikely 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: 71 years.(b2) added check for hospitalization - initial or prolonged.(d4) serial number: (b)(6), expiration date: 19-feb-2028, unique identifier (udi) #: (b)(4).Initial reporter occupation: physician.(g5) pma/510(k)number: k152217.(h3) the loosening reported was likely the result of an insufficient bond between the implant and the bone, which led to aseptic (non-infected) loosening of the tibial component and pain.However, this cannot be confirmed because the component was not available for evaluation.(h4) device manufacture date: 21-feb-2018 (h6) evaluation codes: 1924, 4002 section h11: *the following sections have corrected information: (e2) health professional?: yes.(g3) should of been checked health professional on initial report.*no information provided in the following section(s): b6, g8, d7, d11,g8, h7, h9.

• Brand Name: VANTAGE
• Type of Device: TIBIAL PLATE FB SZ 3 RT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8449381
• MDR Text Key: 139750714
• Report Number: 1038671-2019-00179
• 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: 03/27/2020

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: 350-12-03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 93