MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number GLENOSPHERE, 36MM

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 12/15/2023

Event Type  Injury  

Event Description

It was reported, a male patient, initial right reverse tsa implanted on (b)(6) 2019, underwent a revision procedure on (b)(6) 2023, approximately 4 years 3 months post the initial procedure.The patient presented to the surgeon¿s office with complaints of dissatisfaction with their reverse shoulder.Upon examination and imagining, the patient was scheduled for a revision reverse tsa.The surgeon noticed scapular notching on the imaging.During the revision surgery, the surgeon saw the notching on the poly implant.The surgeon found that the central glenosphere screw was loose and not properly securing the glenosphere to the baseplate.The glenosphere screw was removed and the glenosphere was removed.There was prominent metalosis behind the glenosphere implant and around the baseplate implant.The tissue around the baseplate was debrided, and the baseplate was checked for stability.The surgeon thinks the loose fit of the glenosphere around the baseplate without a taper mechanism potentially causes micromotion, then loosening of the screw due to micromotion causes metal on metal reaction within the joint.The joint was irrigated well.A new and larger size and lateralized glenosphere 40mm was implanted.Trialing was performed, and then a new thicker tray and liner were implanted.The patient was revised to a eq reverse torque defining screw kit a801510 320-20-00 (comments: not implanted eq reverse torque defining screw kit a660752 320-20-00), equinoxe reverse tray adapter plate tray +5 a615757 320-10-05, eq rev locking screw a750082 320-15-05, 145-deg pe 40mm hum liner +2.5 a667861 320-40-03, and an expanded glenosphere, 40mm, for small reverse a734556 320-32-40.There was a 5-15 minute surgical delay during the procedure to debride metalosis around the glenoid baseplate implant with no adverse event to the patient as a result.There were no device breakages during the procedure.The patient was last known to be in stable condition following the event.An x-ray was provided.No device returns available as they were discarded by the facility.No device images were provided.No further information.

Manufacturer Narrative

D10: concomitants: 5765131 - 300-30-09 - equinoxe preserve stem 9mm.6017853 - 319-01-32 - steinmann pin sterile 3.2mm x 178mm.6141376 - 320-10-00 - equinoxe reverse tray adapter plate tray +0.6023572 - 320-15-05 - eq rev locking screw.(b)(6) - 320-20-00 - eq reverse torque defining screw kit.(b)(6) - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(6) - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(6) - 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6) - 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6) 320-31-36 - glenosphere, 36mm.(b)(6) 320-35-01 - small glenoid plate.(b)(6) 320-36-00 - 36mm humeral liner +0 unconstrained.(b)(6) 321-52-07 - 3.2mm drill bit sterile.Additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: EQUINOXE
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18576668
• MDR Text Key: 333661280
• Report Number: 1038671-2024-00129
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862534934
• UDI-Public: 10885862534934
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180632
• 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
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GLENOSPHERE, 36MM
• Device Catalogue Number: 320-31-36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2023
• Date Device Manufactured: 02/01/2019
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male