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

Model Number 320-42-03

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant medical device(s): 320-01-42, (b)(4) ; equinoxe reverse 42mm glenosphere; 320-10-00, (b)(4); equinoxe reverse tray adapter plate tray +0.

Event Description

As reported, approximately 27 months post-op the initial l shoulder tsa, the patient reported he "felt" the humeral liner discomfort.During the revision procedure the surgeon discovered the poly was disengaging from the adaptor tray in the patient.The surgeon was unsure why the poly would disengage from the adaptor tray.The patient is a (b)(6)- yr old male, and a truck driver who gets in and out of his cab daily.Patient was last known to be in stable condition following the event.Devices to be returned.

Manufacturer Narrative

(h3) the revision reported was likely the result of significant amounts of stress being applied to the implant construct over time while patient reportedly entered/exited his truck cab throughout the work day, which resulted to disassociation of the humeral liner from the humeral tray.

• 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: 10937101
• MDR Text Key: 219321578
• Report Number: 1038671-2020-00634
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2023
• Device Model Number: 320-42-03
• Device Catalogue Number: 320-42-03
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR