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

Catalog Number	320-02-42
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Metal Related Pathology (4530)
Date of Event	10/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 5 years and 9 months post initial left total shoulder arthroplasty (tsa) for secondary arthritis and a massive rotator cuff tear and approximately 2 years and 5 months post revision for prosthetic dislocation caused by disassembly of the polyethylene insert, a second revision was performed due to pain reported by the patient at which time the glenosphere, humeral liner, and humeral adapter tray were replaced.The humeral liner was changed to a constrained humeral liner.Despite the revisions, the insert continued to disassemble, and the inner joint exhibited an unusual brownish discoloration indicating metallosis.Event and patient outcome were not provided.Products returned.
Additional Manufacturer Narrative
Report numbers: 1038671-2024-04528 and 1038671-2024-04529 e1: phone number (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-04528 and 1038671-2024-04529.The revision reported was likely the result of disassembly between the humeral liner and humeral tray leading to subsequent metal-on-metal articulation between unintended components.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 disassembly of the humeral liner cannot be confirmed from the reported information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 21344621
• Report Number: 1038671-2025-00783
• Device Sequence Number: 12752337
• Product Code: KWS
• UDI-Device Identifier: 10885862186768
• UDI-Public: 10885862186768
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 02/10/2025

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: 320-02-42
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male