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

Catalog Number	320-15-01
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: the revision reported may have been due to either off-axis seating of the glenosphere on the baseplate or incomplete seating of the glenosphere locking screw at the time of implantation.Incomplete seating of the screw may have been due to bone graft or allograft being retained on the screw-hole threads of the baseplate, the glenosphere locking screw being cross-threaded into the baseplate, or a combination of the two, which led to the inability to fully seat the glenosphere onto the baseplate.However, this cannot be confirmed as the devices were not returned for evaluation, and images and radiographs were unable to be obtained.D10: humeral stem or stemless 300-01-11.Reverse humeral liner 320-38-00.Reverse humeral tray 320-10-00.
Event or Problem Description
As reported, the patient presented to the surgeon with disassociation of the glenosphere and reported pain and functional impotence.Approximately 2 years and 5 months post the initial left total shoulder arthroplasty, the patient was revised and the glenosphere removed.Outcome: resolved.The case report form indicates this event is definitely not related to the devices or procedure.

• Brand Name: EQ REV GLENOID PLATE
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22080160
• Report Number: 1038671-2025-02134
• Device Sequence Number: 15631074
• Product Code: KWT
• UDI-Device Identifier: 10885862086488
• UDI-Public: 10885862086488
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2025

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 Catalogue Number: 320-15-01
• 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: 05/04/2023
• Initial Report FDA Received Date: 05/23/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White