MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 46MM HUMERAL LINER +2.5

Model Number	320-46-03
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	05/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation: concomitant medical device(s): 320-01-46, 5787150 - equinoxe reverse 46mm glenosphere; 320-15-05, 5722834 - eq rev locking screw; 320-10-00, 5775079 - equinoxe reverse tray adapter plate tray +0; 320-20-00, 5666835 - eq reverse torque defining screw kit; 300-01-13, 5683442 - equinoxe, humeral stem primary, press fit 13mm.
Event or Problem Description
Approximately 10 weeks postop the initial left tsa, an (b)(6) y/o male patient¿s poly became disengaged in the left shoulder causing a revision.The surgeon wanted to revise the glenosphere as well.As a result, he ¿rebroke¿ the screw on the tray, and when he went to dislodge the tray from the stem, the entire stem came loose causing a necessary full revision of the humeral side as well.Patient was last known to be in stable condition following the event.Patient was last known to be in stable condition following the event.Device is available for return.Humeral loosening is captured under 1038671-2020-00294.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of may have been the result of incomplete seating of the humeral liner during implantation, forceful contact between the liner and glenoid bone (scapular notching), extreme wear of the liner, or a combination of the three, which led to the humeral liner disassociating from the humeral tray.
Event or Problem Description
Approximately 1 year, 1 month, 28 days postop of the initial left tsa, the patient¿s poly became disengaged in the left shoulder causing a revision.The surgeon wanted to revise the glenosphere as well.As a result, he ¿rebroke¿ the screw on the tray, and when he went to dislodge the tray from the stem, the entire stem came loose causing a necessary full revision of the humeral side as well.Patient was last known to be in stable condition following the event and the clinical report indicates that this event is definitely related to the device(s) and/or to the procedure.
Additional Manufacturer Narrative
After further review of additional information received the following sections b5, g1, g3, g6, h1, h2, h3 and h6 have been updated accordingly.Concomitant devices: 320-01-46, (b)(6) - equinoxe reverse 46mm glenosphere.320-15-05, (b)(6)- eq rev locking screw.320-20-00, (b)(6) - eq reverse torque defining screw kit.300-01-13, (b)(6) - equinoxe, humeral stem primary, press fit 13mm.
Additional Manufacturer Narrative
1038671-2024-03558 this follow-up report is being submitted to relay additional and/or corrected information.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-03558.The following sections were updated: g1, h6.The following sections were corrected: b1, b2, g1, h6.The revision reported was likely the result of may have been the result of incomplete seating of the humeral liner during implantation, forceful contact between the liner and glenoid bone (scapular notching), extreme wear of the liner, or a combination of the three, which led to the humeral liner disassociating from the humeral tray.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE
• Common Device Name: REVERSE 46MM HUMERAL 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 10132399
• Report Number: 1038671-2020-00300
• Device Sequence Number: 19629324
• Product Code: KWT
• UDI-Device Identifier: 10885862086747
• UDI-Public: 10885862086747
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/26/2022
• Device Model Number: 320-46-03
• Device Catalogue Number: 320-46-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 08/14/2020; 09/06/2024; 11/13/2024
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 08/26/2020; 09/17/2024; 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male