MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL HEAD TALL, 41MM (ALPHA)

Model Number EQUINOXE, HUMERAL HEAD TALL, 41MM (ALPHA)

Device Problem Malposition of Device (2616)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 10/01/2018

Event Type  Injury  

Event Description

Revision due to pain.Patient presented with a painful anatomic shoulder and xrays revealed pegs of the caged glenoid below the glenoid in the axilla region.Upon revision the entire glenoid was retrieved from this region with all pegs intact, but the cage left behind in the glenoid.Glenoid was removed and a reverse shoulder was done on the intact humeral stem.Patient is expected to do well.

Manufacturer Narrative

The revision reported was likely the result of deformation of the central cage and incomplete seating of the glenoid component due to the central cage contacting the scapular wall during impaction at the time of the original surgery, which led the central cage disassociating from the central peg of the glenoid component.Having a disassociated glenoid component likely contributed to the patient¿s reported pain.

• Brand Name: EQUINOXE, HUMERAL HEAD TALL, 41MM (ALPHA)
• Type of Device: HUMERAL HEAD
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL
• MDR Report Key: 7978347
• MDR Text Key: 124121116
• Report Number: 1038671-2018-00807
• 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: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE, HUMERAL HEAD TALL, 41MM (ALPHA)
• Device Catalogue Number: 310-02-41
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Date Manufacturer Received: 10/02/2018
• Patient Sequence Number: 1
• Patient Age: 77 YR