MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE SHOULDER COMPONENTS; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	RS GLENOID PLATE SUP AUG, 10 DEG
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient, initial right shoulder implanted on (b)(6) 2023, underwent a revision procedure on (b)(6) 2023, approximately 5 months post the initial procedure.Raised white blood cell markers caused suspected infection & subsequent removal of implants.A cement spacer was implanted.There were no surgical delays or device breakages reported.No x-rays were able to be obtained.The patient was last known to be in stable condition following the event.No device returns are available as they were disposed of.Explant images were provided.No further information.
Additional Manufacturer Narrative
D10: concomitants: a225883 - 300-01-13 - equinoxe, humeral stem primary, press fit 13mm; a506589 - 315-35-00 - glnd kwire; a481881 - 320-01-38 - equinoxe reverse 38mm glenosphere; a365193 - 320-10-00 - equinoxe reverse tray adapter plate tray +0; a323044 - 320-15-02 - rs glenoid plate sup aug, 10 deg; a550161 - 320-15-05 - eq rev locking screw; a522025 - 320-20-00 - eq reverse torque defining screw kit; a554000 - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm; a496549 - 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm; s362925 - 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm; s408589 - 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm; a581966 - 20-38-00 - equinoxe reverse 38mm humeral liner +0; a377790 - 321-20-00 - equinoxe reverse shoulder drill kit; a515293 - 321-20-00 - equinoxe reverse shoulder drill kit.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Investigation results: the cause and type of the patient¿s infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted devices and the patient due to patient illness, unique anatomy, or other condition.There is no patient clinical information provided.The photos do not show wear, there is no mention of device malfunction or wear from the reporter.Deep and superficial infections are a known general surgical risk.These devices are used for treatment not diagnosis.There is no other information available.

• Brand Name: EQUINOXE REVERSE SHOULDER COMPONENTS
• 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: matt collins ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18522437
• Report Number: 1038671-2024-00097
• Device Sequence Number: 3665187
• Product Code: KWS
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2026

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 Model Number: RS GLENOID PLATE SUP AUG, 10 DEG
• Device Catalogue Number: 320-15-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/04/2024; 06/16/2026
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 04/04/2024; 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown