MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE 42MM HUMERAL LINER +0

Catalog Number 320-42-00

Device Problem Break (1069)

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

Event Date 06/03/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant medical devices: 320-01-42, 2222572, glenoshphere 42mm; 320-10-00, 2675511, reverse humeral adapter tray +0; 320-15-05, 2675817, glenosphere locking screw; 320-20-00, 2705296, torque defining screw kit.

Event Description

Primary surgery: (b)(6) 2019.Revision due to pain.Patient's liner was broken and was having pain.

Manufacturer Narrative

Section h10: file was determined to be a duplicate of 1038671-2019-00346.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE REVERSE 42MM HUMERAL LINER +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8739272
• MDR Text Key: 149345912
• Report Number: 1038671-2019-00336
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

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: Health Professional
• Device Expiration Date: 01/07/2017
• Device Catalogue Number: 320-42-00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2019
• Supplement Dates Manufacturer Received: 08/20/2019
• Supplement Dates FDA Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR