MAUDE Adverse Event Report: EXACTECH, INC. GLENOSPHERE, 40MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	320-31-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient's right shoulder was revised approximately 9 months post initial operation.The revision was due to an infection.Surgeon exchanged the liner and glenosphere.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Concomitants: 320-10-00 - equinoxe rev 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 comp screw lck cap kit, 4.5 x 18mm: (b)(6), 320-20-22 - eq rev comp screw lck cap kit, 4.5 x 22mm: (b)(6), 320-20-26 - eq rev comp screw lck cap kit, 4.5 x 26mm: (b)(6), 320-20-30 - eq rev comp screw lck cap kit, 4.5 x 30mm: (b)(6), 320-31-40 - glenosphere, 40mm for small reverse: (b)(6), 320-35-02 - small superior augment glenoid plate: (b)(6), 320-40-00 - humeral liner, 40mm, +0: (b)(6).H3: the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: h6.The reason for the reported revision due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition.Additionally, infection is a known surgical risk, as outlined in the ifu.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: GLENOSPHERE, 40MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22216089
• Report Number: 1038671-2025-02303
• Device Sequence Number: 8748383
• Product Code: PHX
• UDI-Device Identifier: 10885862534972
• UDI-Public: 10885862534972
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,Followup
• Report Date (Section B): 06/25/2025

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: 320-31-40
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2023
• 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
• Patient Age: 80 YR
• Patient Sex: Male