MAUDE Adverse Event Report: EXACTECH, INC EQUINOXE REVERSE GLENOSPHERE

Catalog Number 320-01-42

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 05/31/2016

Event Type  malfunction  

Manufacturer Narrative

Engineering evaluation noted that the revision reported was likely the result of not fully seating the torque defining screw during the initial implantation, which prevented the humeral liner from fully assembling to the adapter tray, leading to disassociation.Associated with 1038671-2016-00396, 1038671-2016-00495, 1038671-2016-00496, and 1038671-2016-00626.

Event Description

Index surgery: (b)(6) 2013.Revision of reverse shoulder components three years after original surgery due to humeral tray disassociation.

• Brand Name: EQUINOXE REVERSE GLENOSPHERE
• Type of Device: GLENOSPHERE
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 5976468
• MDR Text Key: 55616547
• Report Number: 1038671-2016-00625
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2016

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: Physician
• Device Catalogue Number: 320-01-42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 09/26/2016
• 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: 75 YR
• Patient Weight: 120