MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE SHOULDER COMPONENTS; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	320-01-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
Date of Event	06/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial right tsa on (b)(6) 2016.The patient presented with swelling and pain in their right shoulder.The surgeon opened the shoulder and found frank pus in joint.The glenosphere, tray and liner were removed, but could not get the stem out.Decision to perform dair procedure made.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending investigation.D10: 4113807 300-01-11 - equinoxe, humeral stem primary, press fit 11mm.4277010 315-35-00 - glnd kwire.4279690 320-10-00 - equinoxe reverse tray adapter plate tray +0.4279907 320-15-01 - eq rev glenoid plate.4257768 320-15-05 - eq rev locking screw.4248153 320-20-00 - eq reverse torque defining screw kit.4126613 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.4277156 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.4252666 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.4129894 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.2233357 320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm.4246059 320-38-00 - equinoxe reverse 38mm humeral liner +0.4332952 321-20-00 - equinoxe reverse shoulder drill kit.
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
Additional Manufacturer Narrative
Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5, d1, d4 (remove expiration date), d8, f10 (remove data from initial), g1, g4, h4 (remove manufactured date), h6: clinical code, type of investigation, investigation findings and investigation conclusion.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
As reported, the patient had an initial right tsa.The patient presented with swelling and pain in their right shoulder.The surgeon opened the shoulder and found frank pus in joint.The glenosphere, tray and liner were removed, but could not get the stem out.Decision to perform dair procedure made.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.

• Brand Name: EQUINOXE SHOULDER COMPONENTS
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17330010
• Report Number: 1038671-2023-01664
• Device Sequence Number: 17523653
• Product Code: HSD
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/06/2026
• Device Model Number: 320-01-38
• 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: 06/29/2023
• Supplement Date Received by Manufacturer: 12/15/2023; 02/07/2026
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 12/19/2023; 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2016
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female