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

Model Number 320-42-13

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 12/03/2021

Event Type  Injury  

Event Description

As reported, this male patient required a left 2nd stage revision, the poly had dislocated from the tray.Upon inspection, the patient required a revision of the poly and the tray, -zero tray to a +10 tray.The locking screw was cold welded and needed to be diamond sawed for it to be removed.Patient was last known to be in stable condition following the event.

Manufacturer Narrative

Pending evaluation.Concomitant medical device(s): 320-20-00, 4590223 - eq reverse torque defining screw kit; 320-15-05, 4573656 - eq rev locking screw; 320-10-00, 4573805 - equinoxe reverse tray adapter plate tray +0; 320-02-42, 3951501 - rs expanded glenosphere 42mm, +4mm offset.

Manufacturer Narrative

Pending evaluation.Concomitant medical device(s): 320-20-00, (b)(4) - eq reverse torque defining screw kit; 320-15-05, (b)(4) - eq rev locking screw; 320-10-00, (b)(4) - equinoxe reverse tray adapter plate tray +0; 320-02-42, (b)(4) - rs expanded glenosphere 42mm, +4mm offset.

Event Description

As reported, this male patient required a left 2nd stage revision, the poly had dislocated from the tray.Upon inspection, the patient required a revision of the poly and the tray, -zero tray to a +10 tray.The locking screw was cold welded and needed to be diamond sawed for it to be removed.Patient was last known to be in stable condition following the event.

Manufacturer Narrative

(h3) the revision reported was likely the result of the surgeon attempting to reduce the shoulder following dislocation, incomplete seating of the liner during implantation, bone impingement, patient-related conditions, or any combination of these possibilities, which led to humeral liner disassociation.The inability to remove the torque defining screw during the revision was likely the result of the screw being cold welded in the humeral stem/humeral tray assembly.However, this cannot be confirmed as the devices and pre-revision x-rays were not available for evaluation.

• Brand Name: EQUINOXE
• Type of Device: REVERSE 42MM HUMERAL CONST LINER +2.5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 13061557
• MDR Text Key: 285620714
• Report Number: 1038671-2021-00730
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086723
• UDI-Public: 10885862086723
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2020
• Device Model Number: 320-42-13
• Device Catalogue Number: 320-42-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male