MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; TIBIAL INSERT FB SZ 1 LT 7MM

Catalog Number 350-11-02

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); Swelling (2091)

Event Date 12/03/2018

Event Type  Injury  

Manufacturer Narrative

This event report was received through clinical data collection activities.Pending evaluation.

Event Description

Index surgery: (b)(6) 2018.At a post-op visit, the patient reported left hip pain and presented with left leg swelling.Per the treating surgeon, the symptoms may indicate possible tibial loosening (with osteolysis).Action taken: vitamin d and calcium supplements; compression hose.The case report form indicates this event is possibly related to devices and possibly related to procedure.

Manufacturer Narrative

The pain and swelling reported may be the result of aseptic (non-infected) loosening, which could damage the bond of the implant to the bone.

• Brand Name: VANTAGE
• Type of Device: TIBIAL INSERT FB SZ 1 LT 7MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 8159442
• MDR Text Key: 130171926
• Report Number: 1038671-2018-00945
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2018

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: 350-11-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 12/06/2018
• Supplement Dates FDA Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 74