MAUDE Adverse Event Report: EXACTECH, INC. RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-15-04
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 320-42-03 - 145-deg pe 42mm hum liner +2.5 : a123998.320-42-13 - 145-deg pe 42mm const hum liner +2.5 : 5813501.300-30-08 - equinoxe preserve stem 8mm : a266456.320-06-42 - glenosphere 42mm : a196131.320-10-00 - equinoxe reverse tray adapter plate tray +0 : a299979.320-15-05 - eq rev locking screw : a281449.320-20-00 - eq reverse torque defining screw kit : a232424.320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm : s397211.521-78-32 - threaded pin size 3.0 collarless 2pk : s386855.531-55-88 - ergo gps 3.2mm drill kit sterile : a063925.315-35-00 - glnd kwire : a228734.315-35-00 - glnd kwire : a228735.320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm : a208986.320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm : s387405.(h3) pending evaluation.
Event or Problem Description
As reported by the equinoxe shoulder study, the 76-year-old non-hispanic white female had a right tsa on (b)(6) 2022.The patient present with other scapular fracture on (b)(6) 2023.The patient had to use her right arm for transfer after postop ankle fracture and developed a glenoid (non-displaced).No action was taken for this event and the outcome is considered resolved on (b)(6) 2023.The case report form indicates that this event is unlikely related to the device and possibly related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
The reason for the post operative bone fracture reported cannot be conclusively determined but may be related to implant positioning, patient bone quality, a trauma, and/or another patient related condition.However, this cannot be confirmed based on the information provided.

• Brand Name: RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT
• 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19217937
• Report Number: 1038671-2024-01016
• Device Sequence Number: 12498105
• Product Code: KWS
• UDI-Device Identifier: 10885862186690
• UDI-Public: 10885862186690
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 320-15-04
• 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: 04/09/2024
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2022
• 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 H10
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White