MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; RS GLENOID PLATE L POST AUG, 8 DEG, LEFT

Model Number	320-15-03
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant device(s): 300-30-06, 5639974 - equinoxe preserve stem 6mm.320-01-46, 5767789 - equinoxe reverse 46mm glenosphere.320-10-00, 5888995 - equinoxe reverse tray adapter plate tray +0.320-46-03, 5285948 - equinoxe reverse 46mm humeral liner +2.5.
Event or Problem Description
As reported by an equinoxe shoulder study, approximately 3 years post op the initial tsa, this (b)(6) y/o male patient was experiencing aseptic glenoid loosening.Patient was pushing a shopping cart, felt pop, and had increased pain.Surgeon ordered a ct scan and the outcome is still continuing.The case report form indicates this event is unlikely related to devices and definitely not related to procedure.This event report was received through clinical data collection activities.
Additional Manufacturer Narrative
Section h10: (h3) the revision captured may have been the result of both patient-related conditions and an insufficient bond between the glenoid component and the bone, which led to aseptic (non-infected) glenoid loosening.However, this cannot be confirmed as the devices were not returned for evaluation and pre-revision x-rays were unable to be obtained.Section h11: *the following sections have corrected information: (h6) component code: 7455, part/component/sub-assembly term not applicable.

• Brand Name: EQUINOXE
• Common Device Name: RS GLENOID PLATE L POST AUG, 8 DEG, 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: 14567470
• Report Number: 1038671-2022-00629
• Device Sequence Number: 17417261
• Product Code: KWT
• UDI-Device Identifier: 10885862186683
• UDI-Public: 10885862186683
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

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: 320-15-03
• Device Catalogue Number: 320-15-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2018
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White