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

Catalog Number 9999

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Fall (1848)

Event Type  Injury  

Manufacturer Narrative

This event report was received through clinical data collection activities.Pending evaluation.

Event Description

Index surgery: (b)(6) 2015.Aseptic glenoid loosening.Poly sheared of tra, possibly due to patient fall.No action taken.The case report form indicates this event is definitely related to devices and possibly related to procedure.

Manufacturer Narrative

This event report was received through clinical data collection activities.The glenoid loosening reported was likely the result of the patient's fall, which likely caused a fracture of the cage glenoid.

• Brand Name: CAGE GLENOID
• Type of Device: CAGED GLENOID
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 8085236
• MDR Text Key: 127603320
• Report Number: 1038671-2018-00883
• 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: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 66