MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 42MM HUMERAL LINER +2.5

Model Number 320-42-03

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 09/16/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 320-15-05, eq rev locking screw, 320-01-42, 69012018, equinoxe reverse 42 mm glenosphere.

Event Description

It was reported that a patient had a revision due to a liner disassociation from the humeral adapter tray.During the revision, the surgeon noted that the glenosphere screw was loose and backing out allowing the glenosphere to loosen from the glenoid plate.

Manufacturer Narrative

Section h10: (d4) serial number: (b)(6), expiration date: 14-feb-2021 (h3) the revision reported may have been the result of not fully seating the humeral liner in the humeral tray at the time of implantation, which led to humeral liner disassociation.(h4) device manufacture date: 16-feb-2016.(h6) evaluation codes:1924, 2923.

• Brand Name: EQUINOXE
• Type of Device: REVERSE 42MM HUMERAL LINER +2.5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9191980
• MDR Text Key: 162649400
• Report Number: 1038671-2019-00501
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086709
• UDI-Public: 10885862086709
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• 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: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2021
• Device Model Number: 320-42-03
• Device Catalogue Number: 320-42-03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention