MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE POLY

Model Number SPECIFIC DEVICE NOT REPORTED

Device Problem Unstable (1667)

Patient Problem Cyst(s) (1800)

Event Date 10/18/2018

Event Type  Injury  

Manufacturer Narrative

Pending device return and evaluation.

Event Description

Revision due to instability.Patient has cysts around the glenoid.

Manufacturer Narrative

The revision reported was likely the result of joint instability and may have been related to the patient's rheumatoid arthritis.

• Brand Name: EQUINOXE POLY
• Type of Device: POLY
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th 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: 8028788
• MDR Text Key: 125904787
• Report Number: 1038671-2018-00852
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 9999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/18/2018
• Date Manufacturer Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR