MAUDE Adverse Event Report: EXACTECH, INC. GLENOSPHERE EXP 42MM +4MM OFFSET; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-08-42
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitants: 320-15-05 - eq rev locking screw (b)(6).320-15-01 - eq rev glenoid plate (b)(6).320-15-05 - eq rev locking screw (b)(6).320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm (b)(6).320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm (b)(6).320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm (b)(6).
Event or Problem Description
As reported, approximately one year and eight months post total shoulder arthroplasty (tsa), the patient underwent a revision of the right hybrid reverse shoulder due to the glenosphere and glenosphere locking screw backing out away from a well fixed reverse baseplate.It was noted that the patient was involved in an atv accident that may have affected the prosthesis.The surgeon replaced the glenosphere and glenosphere locking screw.There was no reported device breakage or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined that this device did not cause or contribute to the reported event.As a result, this complaint event is no longer considered reportable by exactech and this report may be disregarded.

• Brand Name: GLENOSPHERE EXP 42MM +4MM OFFSET
• 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 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20569429
• Report Number: 1038671-2024-04183
• Device Sequence Number: 7460299
• Product Code: KWT
• UDI-Device Identifier: 10885862563729
• UDI-Public: 10885862563729
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K193098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 320-08-42
• 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: 10/14/2024
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 46 KG