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

Model Number 320-15-02

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 01/20/2022

Event Type  Injury  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 293551193
• Report Number: 1038671-2022-00650
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862186676
• UDI-Public: 10885862186676
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White