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

Catalog Number	320-35-01
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Aseptic loosening (4883)
Date of Event	09/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6), 300-30-09 - equinoxe preserve stem 9mm.(b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6), 320-15-05 - eq rev locking screw.(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), 320-20-22 - 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), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(6), 320-31-36 - glenosphere, 36mm.(b)(6), 320-35-01 - small glenoid plate.(b)(6), 321-52-07 - 3.2mm drill bit sterile.(b)(6), 321-52-09 - 3.2mm k-wire, trocar tip.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
As reported, approximately 4 years and 9 months post the initial reverse total shoulder arthroplasty, the patient presented to the surgeon's office with complaints of pain and stiffness in their right shoulder.Upon examination and x-ray imaging it appears there are changes around the glenoid implant, indicating bone loss and possible loosening of the glenoid baseplate implant.There are changes and bone resorption shown around the humeral stem as well.The patient was scheduled for a revision right total shoulder arthroplasty with removal of implants and reimplantation of a stable reverse construct.The patient was revised and the original humeral tray, liner, glenosphere, glenosphere screw, peripheral screws and caps, and the baseplate were removed.The humeral stem was well fixed and was retained.The shoulder joint and bone were debrided and prepped for re-implant of a competitor's reverse glenoid baseplate and glenosphere.An exactech humeral tray and liner were implanted on the retained stem and matched to the size of the competitor 36mm glenosphere.The patient left the operating room stable.

• Brand Name: SMALL 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
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 23403954
• Report Number: 1038671-2025-03209
• Device Sequence Number: 15641631
• Product Code: KWT
• UDI-Device Identifier: 10885862534866
• UDI-Public: 10885862534866
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/28/2025

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: 320-35-01
• 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: 10/08/2025
• Initial Report FDA Received Date: 10/28/2025
• Date Device Manufactured: 11/20/2020
• 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 H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male