MAUDE Adverse Event Report: EXACTECH, INC. RS GLENOID PLATE SUP AUG, 10 DEG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-15-02
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Aseptic loosening (4883)
Date of Event	11/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 300-01-10 - equinoxe humeral stem primary press fit 10mm: (b)(6).320-06-38 - glenosphere 38mm: (b)(6).320-15-05 - eq rev locking screw: (b)(6).320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm: (b)(6).320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm: (b)(6).320-20-00 - eq reverse torque defining screw kit: (b)(6).322-10-00 - humeral adapter tray, +0: (b)(6).322-38-00 - 145-deg pe 38mm hum liner +0: (b)(6).Customer has indicated that the product is in process of being returned for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent an initial left reverse total shoulder arthroplasty.Subsequently, the patient experienced pain and decreased motion in the shoulder.As a result, the patient underwent a left shoulder revision approximately 1 year after initial implantation.During the revision surgery it was noted that one of the patient's glenoid screws had fractured which led to loosening of the glenoid baseplate.The distal portion of the screw was retained in the patient's glenoid.No further patient impact reported.No further information available.This is report 2 of 2 for this event.

• Brand Name: RS GLENOID PLATE SUP AUG, 10 DEG
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 23716153
• Report Number: 1038671-2025-03483
• Device Sequence Number: 18712941
• Product Code: KWS
• UDI-Device Identifier: 10885862186676
• UDI-Public: 10885862186676
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 12/04/2025

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: 320-15-02
• 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: 11/15/2025
• Initial Report FDA Received Date: 12/04/2025
• Date Device Manufactured: 09/25/2024
• 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; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female