MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE GLENOSPHERE

Model Number EQUINOXE REVERSE 38MM GLENOSPHERE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 10/16/2018

Event Type  Injury  

Manufacturer Narrative

Pending engineering evaluation.

Event Description

Dr.(b)(6) had a patient with persistent pain.Films and cultures revealed nothing unusual.His decision was to remove all components and allow the humerus to heal onto the glenoid through a resection arthroplasty.All implants were removed with care to remove as little bone as possible.All components looked good when explanted and nothing seemed unusual.He is not sure why the patient was experiencing persistent pain.Patient outcome is expected to be good.

Manufacturer Narrative

The revision reported was likely the result of pain.The surgeon stated, "all components looked good when explanted and nothing seemed unusual.".

• Brand Name: EQUINOXE REVERSE GLENOSPHERE
• Type of Device: GLENOSPHERE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 8045580
• MDR Text Key: 126357417
• Report Number: 1038671-2018-00854
• 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
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE 38MM GLENOSPHERE
• Device Catalogue Number: 320-01-38
• 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: 64 YR