MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; 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	08/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The revision reported was likely the result of an insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the glenoid baseplate.However, this cannot be confirmed because the component was not returned for evaluation.Concomitant device(s): 300-30-10, equinoxe preserve stem 10mm 320-38-00, equinoxe reverse 38mm humeral liner +0 320-10-00, equinoxe reverse tray adapter plate tray +0 320-01-38, equinoxe reverse 38mm glenosphere *no information provided.
Event or Problem Description
As reported, approximately 8 months postop the initial right tsa, the patient experienced right aseptic glenoid loosening and was revised.The case report form indicates this event is unlikely related to devices or procedure.This event report was received through clinical data collection activities.The patient has a history of rtc tear and repair, hypertension, and diabetes.Patient was in the hospital for 1 day.Devices will not return to due to study policy.

• Brand Name: EQUINOXE
• Common Device Name: RS GLENOID PLATE SUP AUG, 10 DEG
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11035670
• Report Number: 1038671-2020-00653
• Device Sequence Number: 1034072
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2020

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 84