MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQ REV LOCKING SCREW

Model Number 320-15-05

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/09/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation: concomitant device(s): 320-01-38, 6014829 - equinoxe reverse 38mm glenosphere, 320-38-00, 6095086 - equinoxe reverse 38mm humeral liner +0.

Event Description

As reported, approximately 1 yr.Postop the initial left tsa, this (b)(6) male patient had complained of pain and present to the surgeon.The surgeon took x-rays and noticed the glenosphere was off and saw the locking screw loose inferior in the joint.The patient was revised.The glenosphere and broken locking screw and poly were removed.A new 38 glenosphere, locking screw and poly were replaced.It was noticed upon looking at immediate post op and then another 2 weeks later it was evident that the glenosphere was never completely seated and the locking screw never completely seated.Patient was last known to be in stable condition following the event.Devices to be returned.

Manufacturer Narrative

Section h10: (h3) the revision reported was likely the result of the glenosphere not being fully seated at the time of the initial surgery, which likely did not allow for complete seating of the glenosphere locking screw.The system was intended to transmit forces through the glenosphere to the glenoid baseplate.When not fully seated, it is possible for the forces to be transmitted thought the glenosphere and the locking screw, creating forces on the locking screw that cannot be supported.

• Brand Name: EQUINOXE
• Type of Device: EQ REV LOCKING SCREW
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11086716
• MDR Text Key: 224787834
• Report Number: 1038671-2020-00669
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086495
• UDI-Public: 10885862086495
• 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: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-15-05
• Device Catalogue Number: 320-15-05
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR