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

Model Number	320-15-02
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	04/23/2022
Type of Reportable Event	Serious Injury
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 infection cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
Event or Problem Description
As reported thru equinoxe shoulder study, approximately 2 years post op the initial tsa, this 57 y/o male patient was presenting with a small suspicion for possible infection, subject had labs done and met with id in greenville who prescribed antibiotics indefinitely.The case report form indicates this event is definitely not related to devices and possibly related to procedure.This event report was received through clinical data collection activities.No additional information.
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 infection 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 all from the initial report-suspect device unknown), d8, g1, h4 (remove manufactured dates), h6: clinical code, impact code, type of investigation and investigation findings.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
As reported thru equinoxe shoulder study, approximately 2 years post op the initial tsa, this male patient was presenting with a small suspicion for possible infection, subject had labs done and met with id in greenville who prescribed antibiotics indefinitely.The case report form indicates this event is definitely not related to devices and possibly related to procedure.This event report was received through clinical data collection activities.No additional information.

• Brand Name: EQUINOXE PRIMARY SHOULDER COMPONENTS
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 15347003
• Report Number: 1038671-2022-01014
• Device Sequence Number: 5143681
• Product Code: KWT
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• 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): 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 320-15-02
• 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: 05/18/2022
• Supplement Date Received by Manufacturer: 02/14/2026
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2019
• 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; SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 76 KG