MAUDE Adverse Event Report: Exactech, Inc. RS GLENOID PLATE L POST AUG, 8 DEG, LEFT; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Catalog Number	320-15-03
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient underwent a left shoulder replacement.Subsequently, they were revision due to instability involving the glenoid aspect.Intraoperatively, the glenoid baseplate and glenosphere construct were noted to be posteriorly rotated.During removal of the glenosphere, the glenoid components were removed concurrently with the glenosphere.All implanted components were subsequently explanted and revised to a competitor's hemiarthroplasty.Polyethylene wear of the humeral liner was also observed.The patient was last known to be in stable condition following the event.

• Brand Name: RS GLENOID PLATE L POST AUG, 8 DEG, LEFT
• 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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66 ct; gainesville, FL 32653 ; +1(352)377-1140
• MDR Report Key: 50068263
• Report Number: 1038671-2026-00954
• Device Sequence Number: 10250860
• Product Code: KWS
• UDI-Device Identifier: 10885862186683
• UDI-Public: 10885862186683
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• 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): 07/29/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 320-15-03
• 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: 07/13/2026
• Initial Report FDA Received Date: 07/29/2026
• Date Device Manufactured: 12/13/2022
• 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: Hospitalization
• Patient Sex: Male