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

Catalog Number	320-02-42
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	07/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial reverse total shoulder replacement on the right side.Subsequently, the patient experienced the disassembly and migration of the polyethylene component.As a result, approximately 2 years after initial replacement, the patient underwent a right shoulder revision.No further impact to the patient was reported.No other information is available.
Additional Manufacturer Narrative
The revision reported was likely the result of disassembly between the humeral liner and humeral tray and subsequent migration of the humeral liner.The reported wear of the adapter tray and glenosphere was likely due to the migration of the liner and subsequent metal-on-metal articulation between the tray and glenosphere.The migration of the liner may have been the result of disassociation from the tray and internal forces in vivo.However, this cannot be confirmed and potential contributions from patient conditions, an unreported traumatic event, incomplete seating of the humeral liner during implantation, forceful contact between the liner and glenoid bone (scapular notching), or a combination of the above to the reported disassembly of the humeral liner cannot be determined as the devices were not returned for evaluation and images/radiographs were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: RS EXPANDED GLENOSPHERE 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
• MDR Report Key: 23291268
• Report Number: 1038671-2025-03107
• Device Sequence Number: 20049177
• Product Code: KWT
• UDI-Device Identifier: 10885862186768
• UDI-Public: 10885862186768
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2025

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
• Device Catalogue Number: 320-02-42
• 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: 09/24/2025
• Initial Report FDA Received Date: 10/15/2025
• Date Device Manufactured: 06/22/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 70 KG