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

Model Number	320-46-03
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 320-15-05, 5892026 - eq rev locking screw.320-20-00, 5835775 - eq reverse torque defining screw kit.320-01-46, 5767833 - equinoxe reverse 46mm glenosphere.320-10-00, 5952251 - equinox reverse tray adapter plate tray.
Event or Problem Description
As reported, approximately 1 year postop of the initial shoulder implant, this (b)(6) y/o male patient presented with complaints of decreased function in arm/shoulder.Upon examination, it was determined that the polyethylene had disassociated.A revision to a reverse shoulder was completed.No postop problems reported.Patient has history of underlying end-stage osteoarthrosis, hypertension, heart disease, hyperthyroidism, and hypercholesterolemia.This event report was received through clinical data collection activities.
Additional Manufacturer Narrative
The revision reported is likely 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 humeral liner, patient conditions, or a combination of the four, which led to the humeral liner disassociating from the humeral tray.However, this cannot be confirmed as the explants not returned for evaluation.

• Brand Name: EQUINOXE
• Common Device Name: REVERSE 46MM HUMERAL LINER +2.5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10152649
• Report Number: 1038671-2020-00304
• Device Sequence Number: 2164542
• Product Code: KWT
• UDI-Device Identifier: 10885862086747
• UDI-Public: 10885862086747
• Combination Product (Y/N): N
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/14/2021
• Device Model Number: 320-46-03
• Device Catalogue Number: 320-46-03
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 91