MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; 8.5MM PLATFORM FX STEM LEFT

Model Number	304-21-09
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 1 year post op the initial left tsa, this (b)(6) male patient's was revised for loosening of the stem due to infection.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Concomitant device(s): 320-15-01, 6585857 - eq rev glenoid plate; 320-01-42, 6700700 - equinoxe reverse 42mm glenosphere; 320-15-05, 6746350 - eq rev locking screw; 320-10-00, 6727094 - equinoxe reverse tray adapter plate tray +0; 320-20-00, 6738026 - eq reverse torque defining screw kit; 320-42-00, 6481862 - equinoxe reverse 42mm humeral liner +0.
Event or Problem Description
As reported, approximately 1 year post op the initial left tsa, this 67 y/o male patient was revised for loosening of the stem due to infection.Patient was last known to be in stable condition following the event.Device not returned, disposed of by hospital.No additional information.
Additional Manufacturer Narrative
Section h10: (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 loosening due to infection cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.Section h11: *the following sections have corrected information: (b5) describe event or problem: as reported, approximately 1 year post op the initial left tsa, this 67 y/o male patient was revised for loosening of the stem due to infection.Patient was last known to be in stable condition following the event.Device not returned, disposed of by hospital.No additional information.

• Brand Name: EQUINOXE
• Common Device Name: 8.5MM PLATFORM FX STEM LEFT
• 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: kate jacobson ; 3523771140
• MDR Report Key: 14521005
• Report Number: 1038671-2022-00618
• Device Sequence Number: 14828333
• Product Code: KWT
• UDI-Device Identifier: 10885862083357
• UDI-Public: 10885862083357
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K092900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

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: 06/27/2026
• Device Model Number: 304-21-09
• Device Catalogue Number: 304-21-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2016
• 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 Age: 67 YR
• Patient Sex: Male