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

Catalog Number	320-31-40
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Aseptic loosening (4883)
Date of Event	02/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported in a clinical study that the patient previously underwent an initial shoulder replacement procedure.Subsequently, the patient developed aseptic glenoid loosening and pain without a known inciting event.No medical or surgical intervention has been undertaken at this time, and the patient is currently under observation.The device remains implanted.No further information is available.
Additional Manufacturer Narrative
D10: 300-30-06 - equinoxe preserve stem 6mm: (b)(6), 320-40-00 - 145-deg pe 40mm hum liner +0: (b)(6), 320-10-00 - eq rev tray adapter platray +0: (b)(6), 320-31-40 - glenosphere, 40mm: (b)(6), 320-35-07 - sm sup/posr aug glen plate,left: (b)(6), 320-15-05 - eq rev locking screw: (b)(6).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.

• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24640738
• Report Number: 1038671-2026-00299
• Device Sequence Number: 9787075
• Product Code: PHX
• UDI-Device Identifier: 10885862534972
• UDI-Public: 10885862534972
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/19/2026

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: 320-31-40
• 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: 02/27/2026
• Initial Report FDA Received Date: 03/19/2026
• Date Device Manufactured: 04/01/2020
• 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
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White