MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL CONST LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-38-10
Medical Device Problem Codes	Unstable (1667); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Joint Laxity (4526); Metal Related Pathology (4530)
Date of Event	10/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 68 yo male patient, initial left shoulder implanted on (b)(6) 2018, underwent a revision procedure on october 31, 2023.The patient¿s tray and poly were revised due to instability.The xray showed the tray right up against the glenosphere, (metal on metal), so the poly had become dislodged.The +0 tray and 38mm +0 constrained liner were swapped for a new +0 tray with a 38mm +2.5 constrained liner.There were no device breakages or surgical delays.The patient was last known to be in stable condition following the event.X-rays were unable to be obtained.The explanted devices are not able to be returned as the hospital does not allow it.Device images were provided.No further information.
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 320-15-06 - rs glenoid plate ext cag +10mm cage peg (b)(6) 320-15-05 - eq rev locking screw (b)(6) 320-38-00 - equinoxe reverse 38mm humeral liner +0 (b)(6) 321-20-00 - equinoxe reverse shoulder drill kit (b)(6) 315-35-00 - glnd kwire 5251874 315-35-00 - glnd kwire (b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0 (b)(6) 320-01-38 - equinoxe reverse 38mm glenosphere (b)(6) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6) 320-15-05 - eq rev locking screw (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) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm (b)(6) 320-20-00 - eq reverse torque defining screw kit additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of disassembly between the humeral liner and humeral tray leading to subsequent metal-on-metal articulation between unintended components, migration, and prosthesis wear.An additional reason for the reported revision may have been instability.However, the reported instability could not be confirmed from the information provided.Potential contributions of patient and user considerations, 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 disassembly of the humeral liner cannot be confirmed from the reported information, as the devices were not available for evaluation and 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 38MM HUMERAL CONST 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18210166
• Report Number: 1038671-2023-02861
• Device Sequence Number: 20395143
• Product Code: KWT
• UDI-Device Identifier: 10885862086679
• UDI-Public: 10885862086679
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

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: 02/28/2021
• Device Catalogue Number: 320-38-10
• 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: 11/01/2023
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 04/29/2025
• Date Device Manufactured: 03/02/2016
• 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: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male