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 Code	Pain (1994)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 300-30-06 - equinoxe preserve stem 6mm: (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0: (b)(6).320-31-40 - glenosphere, 40mm: (b)(6).320-35-07 - small superior/posterior aug glenoid plate,left: (b)(6).320-15-05 - eq rev locking screw: (b)(6).320-20-00 - eq reverse torque defining screw kit: 6710244 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm: (b)(6).320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: (b)(6).320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm: (b)(6).320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm: (b)(6).321-20-00 - equinoxe reverse shoulder drill kit: (b)(6).
Event or Problem Description
As reported by the equinoxe shoulder study, approximately 1 year(s) and 6 month(s) post-operative of right implanted tsa, the patient presented with disassociation of base plate.Patient had a substantial reconstruction procedure done to implement the rtsa prosthesis.This failed, and the patient will undergo surgery again.Patient had been experiencing a sudden increase in pain and was found to have a complete disassociation of the baseplate.
Additional Manufacturer Narrative
The revision reported may be the result of the glenoid loosening as reported.However, the loosening cannot be confirmed and any potential contributions from manufacturing, user, or patient-related contributing factors to the event cannot be evaluated as no radiograph, images, or clinical information was provided.H6: corrected investigation clinical codes.

• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19571228
• Report Number: 1038671-2024-02028
• Device Sequence Number: 18284342
• Product Code: KWS
• UDI-Device Identifier: 10885862186706
• UDI-Public: 10885862186706
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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: 320-15-06
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 05/16/2025
• Date Device Manufactured: 08/08/2017
• 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
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Race: Black Or African American