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

Model Number	RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT
Medical Device Problem Codes	Structural Problem (2506); Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Arthritis (1723); Failure of Implant (1924); Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Bone Notching (4890)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products: equinoxe reverse 38mm glenosphere (cat# 320-01-38 / serial# (b)(6)).Equinoxe reverse 38mm humeral liner +0 (cat# 320-38-00 / serial# (b)(6)).Equinoxe, humeral stem primary, press fit 15mm (cat# 300-01-15 / serial# (b)(6)).Equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / serial# (b)(6)).Eq rev locking screw (cat# 320-15-05 / serial# (b)(6)).Eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(6)).Eq rev compress screw lck cap kit, 4.5 x 22mm (cat# 320-20-22 / serial# (b)(6)).Eq rev compress screw lck cap kit, 4.5 x 26mm (cat# 320-20-26 / serial# (b)(6)).Eq rev compress screw lck cap kit, 4.5 x 38mm (cat# 320-20-38 / serial# (b)(6)).Equinoxe reverse shoulder drill kit (cat# 321-20-00 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the equinoxe shoulder study, approximately 4 year(s) and 9 month(s) post implantation of a right tsa, the patient presented with infection.The patient had rtsa with loose glenosphere + metaglene component without broken hardware and scapular notching.Plan for revision with antibiotic spacer.The patient underwent a standard reverse revision in early 2019 followed with antibiotic spacer procedure later that year.Implantation of antibiotic delivery system due to positive mrsa screen.Patient has cleared infection and desires conversion back to a reverse tsa.The clinical report indicates that the event is definitely related to the device(s) and unlikely related to the procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6, h11.The following sections were corrected: h6.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A review of manufacturing data was performed and no discrepancies relevant to the reported event were found.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from component loosening related to the broken hardware and infection.Potential contributions of user or patient-related considerations to the event could not be assessed, and the sequence of events and root cause cannot be determined because the revised components were not returned for evaluation, and no radiographs or images were 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 R POST AUG, 8 DEG, RIGHT
• Common Device Name: PROSTHESIS, SHOULDER, NON-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
• MDR Report Key: 19481376
• Report Number: 1038671-2024-01775
• Device Sequence Number: 8335887
• Product Code: KWT
• UDI-Device Identifier: 10885862186690
• UDI-Public: 10885862186690
• 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: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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 Expiration Date: 10/05/2022
• Device Model Number: RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2012
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Race: Asian