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

Catalog Number 350-12-03

Device Problem Collapse (1099)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2018.Collapse of ankle back into varus angulation.The case report form indicates this event is possibly related to devices and possibly related to procedure.This event report was received through clinical data collection activities.

Event Description

As reported, in (b)(6) 2019, the 77 y/o male patient¿s right ankle was noted as collapsed back into varus angulation.It is noted as resolved in (b)(6) 2019.The patient weighs180 lbs.And height is 5¿4¿.The initial implant on r ankle was on (b)(6) 2018.The patient has a history of osteoarthritis, heart disease, diabetes, parkinson¿s disease, and gallbladder cancer.The patient has also received corticosteroid injections.The patient uses a cane for ambulation and has been instructed on stretching exercises.The case report form indicates this event is possibly related to devices and possibly related to procedure.This event report was received through clinical data collection activities.

Manufacturer Narrative

Section h10: (a1) patient identifier:(b)(6).(b2) outcomes attributed to adverse event : added check for hospitalization - initial or prolonged.(b5) as reported, in (b)(6) 2019, the 77 y/o male patient¿s right ankle was noted as collapsed back into varus angulation.It is noted as resolved in (b)(6) 2019.The patient weighs180 lbs.And height is 5¿4¿.The initial implant on r ankle was on (b)(6) 2018.The patient has a history of osteoarthritis, heart disease, diabetes, parkinson¿s disease, and gallbladder cancer.The patient has also received corticosteroid injections.The patient uses a cane for ambulation and has been instructed on stretching exercises.The case report form indicates this event is possibly related to devices and possibly related to procedure.This event report was received through clinical data collection activities.(d4) unique identifier (udi) #: (b)(4).(e3) occupation: physician.(g5) pma/510(k)number: k152217.(h3) as reported, in (b)(6) 2019, the 77 y/o male patient¿s the ankle was noted as collapsed back into varus angulation.It is noted as resolved in(b)(6) 2019.The patient weighs180 lbs.And height is 5¿4¿.The initial implant on r ankle was on (b)(6) 2018.The patient has a history of osteoarthritis, heart disease, diabetes, parkinson¿s disease, and gallbladder cancer.The patient has also received corticosteroid injections.The patient uses a cane for ambulation and has been instructed on stretching exercises.The case report form indicates this event is possibly related to devices and possibly related to procedure.This event report was received through clinical data collection activities.According to ifu# 700-096-157 rev.1 - patients should be instructed on the limitations of the prosthesis and the possibility of subsequent surgery.The patient should be cautioned to monitor activities and protect the replaced joint from unreasonable stresses and follow the written instructions of the physician with respect to follow-up care and treatment.Patients should be warned to protect the joint replacement from unreasonable stresses and to follow the treating physician¿s instructions, until anterior wound healing is complete.This device is used for treatment and not diagnosis.Upon review of the available information, there is no evidence that this is a device related problem and no allegation against the device.Implantation of a total joint could result pain, infection, loosening of total joint hardware and the patient should monitor their activity and stresses to the operated ankle.The most likely cause of the reported event is the patient¿s conditions.Section h11: corrections made in the following section(s): (g3) report source: health professional.

• 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: 8449398
• MDR Text Key: 139751144
• Report Number: 1038671-2019-00180
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

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: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 82