MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 42MM HUMERAL CONST LINER +0

Model Number 320-42-10

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 06/29/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 320-11-00, (b)(6) - equinoxe rev torque def screw assembly; 320-10-05, (b)(6) - equinoxe reverse tray adapter plate tray +5; 320-15-05, (b)(6) - eq rev locking screw; 320-01-42, (b)(6) - equinoxe reverse 42mm glenosphere; 320-15-00, (b)(6) - eq reverse locking cap.

Event Description

The patient presented with shoulder pain and decreased motion after having an equinoxe reverse shoulder replacement 11 years ago.Original surgery information is unknown.The patient was scheduled for a left revision reverse tsa.Once the shoulder implants were exposed the poly was examined and found to have movement within the humeral tray.The reverse liner was locked down all the way onto the tray, however, it was spinning or moving from left to right within and while locked into the tray.There was obvious metallosis within the joint.The poly liner was removed from the humeral tray.The torque screw and humeral were removed from the stem.The stem version and stability were checked and found to be stable.Attention was then drawn to the glenoid implants.The glenosphere locking screw and glenosphere were removed.The baseplate was cleaned and checked for loosening.It was found to be stable.After debridement and release of the shoulder anatomy, the surgeon decided to implant the 42 +4mm lateralized glenosphere.It was secured with a new glenosphere locking screw.Attention was drawn back to the humerus where trialing took place to decide on a +5mm humeral tray and a +0mm 42mm humeral liner.The tray and liner were impacted onto the stem and checked for any movement.The humeral liner appeared to be moving abnormally side to side while locked into the humeral tray.Revised to an equinoxe 42mm +4mm lateralized glenosphere with new locking screw, as well as, a new +5mm humeral tray and 42mm +0mm humeral liner.The shoulder was relocated and taken through rom.The revision was completed and the patient left the or stable the surgeon confirmed that the patient's post-op x-rays looked good.The surgeon mentioned that the patient's occupation is a pilot.The devices are to be returned.

Manufacturer Narrative

Section h10: (h3) the revision reported was likely the result of not fully threading the torque defining screw into the humeral tray, which inadequately secured the humeral adapter tray to the humeral stem and prevented the humeral liner from fully seating within the adapter tray.The construct appears to have remained assembled but incomplete seating likely caused the ¿spinning or moving¿ observed during the revision surgery, as well as the metallosis (from contact between the torque defining screw and adapter tray and/or adapter tray and humeral stem) and pain reported.

• Brand Name: EQUINOXE
• Type of Device: REVERSE 42MM HUMERAL CONST LINER +0
• 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: 12217081
• MDR Text Key: 263116766
• Report Number: 1038671-2021-00351
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086716
• UDI-Public: 10885862086716
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-42-10
• Device Catalogue Number: 320-42-10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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