MAUDE Adverse Event Report: EXACTECH, INC. EQ REV LOCKING SCREW; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-15-05
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately seven days post initial right tsa, the patient had revision due to glenosphere disassociation.The glenosphere was secured again and the liner was exchanged.The patient is fine; and likely a user error.There was no breakage of device or surgical delay/procedure.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photos/x-rays.The device is not available for evaluation as the devices were disposed by the hospital.
Additional Manufacturer Narrative
D10: (b)(6), 300-01-11 - equinoxe, humeral stem primary, press fit 11mm, (b)(6), 320-01-38 - equinoxe reverse 38mm glenosphere, (b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0, (b)(6), 320-15-01 - eq rev glenoid plate, (b)(6), 320-20-00 - eq reverse torque defining screw kit, (b)(6), 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm, (b)(6), 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm, (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), 320-38-00 - equinoxe reverse 38mm humeral liner +0, (b)(6), 321-52-07 - 3.2mm drill bit sterile, (b)(6), 321-52-09 - 3.2mm k-wire, trocar tip.The revision reported was likely the result of incomplete seating of the glenosphere locking screw at the time of implantation, which allowed the glenosphere to disassociate from the glenoid baseplate.However, this cannot be confirmed as the devices were not available for evaluation and images/radiographs were unable to be obtained.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQ REV LOCKING SCREW
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 24489628
• Report Number: 1038671-2026-00210
• Device Sequence Number: 5017385
• Product Code: KWT
• UDI-Device Identifier: 10885862086495
• UDI-Public: 10885862086495
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

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 Catalogue Number: 320-15-05
• 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: 10/31/2022
• Initial Report FDA Received Date: 03/02/2026
• Date Device Manufactured: 07/28/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female