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

Device Problems Fracture (1260); Material Fragmentation (1261); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

As reported, this male patient¿s left glenoid was found to be in multiple pieces.On x-ray.Upon revising, multiple pieces were within the joint.The surgeon removed as much as he could find, and the device pieces are being returned for inspection.The surgeon said that the patient did not experience a traumatic event.Patient was last known to be in stable condition following the event.

Manufacturer Narrative

Section h10: (h3) the revision reported was likely the result of failure of the caged glenoid component.The root cause of the failed glenoid could not be determined because adequate information involving the patient and the index surgery was not provided.(h6) 1924, 1260.

• Brand Name: EQUINOXE
• Type of Device: CAGED GLENOID
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10459779
• MDR Text Key: 205308363
• Report Number: 1038671-2020-00507
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention