MAUDE Adverse Event Report: EXACTECH, INC. EUINOXE; RS GLENOID PLATE SUP AUG, 10 DEG

Model Number	320-15-02
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the equinoxe shoulder study, approximately 1.5 years post op the initial tsa, this (b)(6) year old male patient was revised due to septic loosening.At the (b)(6) 2022 visit, there was small suspicion for possible infection, subject had labs done and met with id in greenville who prescribed antibiotics indefinitely.At the (b)(6) 2021 visit, xrays suggested loosening of the glenoid component.At (b)(6) 2021 visit, loosening had progessed.Scheduled for revision (b)(6) 2022.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.
Additional Manufacturer Narrative
Concomitant device(s): 300-01-11 - equinoxe, humeral stem primary, press fit 11mm.320-38-00 - equinoxe reverse 38mm humeral liner +0.320-10-00 - equinoxe reverse tray adapter plate tray +0.320-02-38 - rs expanded glenosphere 38mm, +4mm offset.
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 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.

• Brand Name: EUINOXE
• Common Device Name: RS GLENOID PLATE SUP AUG, 10 DEG
• 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: 14631783
• Report Number: 1038671-2022-00650
• Device Sequence Number: 11740922
• Product Code: KWT
• UDI-Device Identifier: 10885862186676
• UDI-Public: 10885862186676
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2022

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 Model Number: 320-15-02
• Device Catalogue Number: 320-15-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White