MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 46MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-46-00
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); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 300-30-12 - equinoxe preserve stem 12mm: 5126770, 320-10-00 - equinoxe reverse tray adapter plate tray +0: 5171492, 320-01-46 - equinoxe reverse 46mm glenosphere: 5155113, 320-15-01 - eq rev glenoid plate: 5185523, 320-15-05 - eq rev locking screw: 5125547, 320-20-00 - eq reverse torque defining screw kit: 5080453, 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm: 4981000, 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: 5171677, 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm: 5087666, 321-20-00 - equinoxe reverse shoulder drill kit: 5153789, (h3) pending evaluation.
Event or Problem Description
As reported by the equinoxe shoulder study, the patient had a left tsa on (b)(6) 2018 and presented with disassociation of polyethylene, on (b)(6) 2019, patient reached back and had a sharp pain.The outcome of this event is considered resolved on (b)(6) 2021.The action taken was revision-standard reverse with the removal of the torque screw, humeral tray, humeral liner, glenosphere, glenosphere locking screw.The case report form indicates that this event is possibly related to the device and definitely not related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported may have been due to disassembly.However, the reported disassembly could not be confirmed.Potential contributions of user and patient-related considerations to the event, an unreported traumatic event, incomplete seating of the humeral liner during implantation, forceful contact between the liner and glenoid bone (scapular notching), or a combination of the above to the reported disassembly of the humeral liner cannot be determined as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE REVERSE 46MM HUMERAL LINER +0
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18862796
• Report Number: 1038671-2024-00436
• Device Sequence Number: 15527496
• Product Code: KWT
• UDI-Device Identifier: 10885862086730
• UDI-Public: 10885862086730
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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: 11/19/2022
• Device Catalogue Number: 320-46-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2017
• 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.
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Race: White