MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; GLENOID

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 03/29/2019

Event Type  Injury  

Manufacturer Narrative

This event report was received through clinical data collection activities.Pending evaluation.Concomitant medical products; humeral stem.Replicator plate.Torque screw.Humeral head.

Event Description

Revision due to aseptic glenoid loosening.The case report form indicates treatment is resolved.

Manufacturer Narrative

The revision reported was likely the result of aseptic (non-infected) glenoid loosening, which damaged the bond between the implant and the bone.This glenoid component was implanted for nearly 15 years prior to the reported loosening.

• Brand Name: EQUINOXE
• Type of Device: GLENOID
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8515560
• MDR Text Key: 141976187
• Report Number: 1038671-2019-00248
• 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: 06/10/2019

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention
• Patient Weight: 115