MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE GLENOSPHERE, 38MM

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.The patient had 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 GLENOSPHERE, 38MM
• Type of Device: GLENOSPHERE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 8028631
• MDR Text Key: 125904739
• Report Number: 1038671-2018-00850
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• 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
• Distributor Facility Aware Date: 10/18/2018
• Date Manufacturer Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR