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

Model Number	320-01-36
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	09/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical devices: (b)(4), 304-21-11 - 10.5mm, platform fx stem left.(b)(4), 320-01-36 - 36mm, glenosphere.(b)(4), 320-10-00 - equinoxe, reverse tray adapter plate tray +0.(b)(4), 320-15-01 - eq rev, glenoid plate.(b)(4), 320-15-05 - eq rev, locking screw.(b)(4), 320-20-00 - eq reverse, torque defining screw kit.(b)(4), 320-20-18 - eq rev, compress screw lck cap kit, 4.5 x 18mm.(b)(4), 320-20-26 - eq rev, compress screw lck cap kit, 4.5 x 26mm.(b)(4), 320-20-30 - eq rev, compress screw lck cap kit, 4.5 x 30mm.(b)(4), 320-36-03 - 36mm, humeral liner +2.5mm unconstrained.(b)(4), 531-20-00 - shldr, gps rvrs drill kit.(b)(4), 531-78-20 - shouldr gps hex pins kit.(b)(4).A10012 - gps implant kit v2.
Event or Problem Description
As reported, the patient had an initial left tsa on (b)(6) 2022.The surgeon removed the glenosphere and humeral liner, completed a washout and then replaced the components with new ones, due to infection.No breakage of device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.
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 surgical revision for infection cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d1, d4 (remove all from initial report-suspect device unknown), g2 (australia), g4 (remove from initial-unknown) h4 (remove from initial report-unknown), h6: clinical code, component code, types, findings and investigation conclusions.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE PRIMARY SHOULDER COMPONENT
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15675729
• Report Number: 1038671-2022-01356
• Device Sequence Number: 6321118
• Product Code: KWS
• UDI-Device Identifier: 10885862086372
• UDI-Public: 10885862086372
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/30/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 320-01-36
• Device Catalogue Number: 320-01-36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/06/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 02/02/2023; 12/15/2025
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 02/08/2023; 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2021
• 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