MAUDE Adverse Event Report: EXACTECH, INC. RS GLENOID PLATE EXT CAG +10MM CAGE PEG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-15-06
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 300-01-13 - equinoxe, humeral stem primary, press fit 13mm: 2580816.320-01-42 - equinoxe reverse 42mm glenosphere: 2554499.320-10-00 - equinoxe reverse tray adapter plate tray +0; 2550468.320-15-05 - eq rev locking screw: 2484775.320-20-00 - eq reverse torque defining screw kit: 2595540.320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm: 2386087.320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm: 2589404.320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm: 2423329.320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm: 2585856.320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm: 2515538.320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm: 2528129.320-42-00 - equinoxe reverse 42mm humeral liner +0: 2564875.
Event or Problem Description
As reported by the equinoxe shoulder study, the 68-year-old male patient had an initial left tsa on (b)(6)2013 and presented with aseptic glenoid loosening on (b)(6)2023.(b)(6)2013 x-ray showed early lucency around rtsa baseplate that had been revised from tsa with bone grafting.Appeared stable and tolerable until (b)(6)2023.Had sudden pain while brushing teeth.The outcome of this event is considered resolved and the action taken was revision on (b)(6)2024.The case report form indicates that this event is unlikely related to the device and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, h6.Mdr section codes updated/corrected: b, c, d, e, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of glenoid loosening.The reported glenoid loosening could not be confirmed.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: RS GLENOID PLATE EXT CAG +10MM CAGE PEG
• 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: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18763459
• Report Number: 1038671-2024-00308
• Device Sequence Number: 4387250
• Product Code: KWS
• UDI-Device Identifier: 10885862186706
• UDI-Public: 10885862186706
• 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: 2013
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2025

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 Expiration Date: 06/13/2022
• Device Catalogue Number: 320-15-06
• 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: 01/23/2024
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2012
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Race: White