MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 38MM HUMERAL CONST LINER +0

Model Number	300-01-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	10/08/2020
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 may have been due to the suspected infection, leading to loosening of the humeral stem.However, this cannot be confirmed because the component was not returned for evaluation.Concomitant device(s): 320-38-10,5260321 - equinoxe reverse 38mm humeral const liner +0; 320-02-38, 5118417 - rs expanded glenosphere 38mm, +4mm offset; 320-10-00, 6119088 - equinoxe reverse tray adapter plate tray +0; 320-15-05, 6112259 - eq rev locking screw; 320-20-00, 6027501 - eq reverse torque defining screw kit.
Event or Problem Description
Approximately 13 months postop the initial right tsa, this female patient presented with a loose humeral component from a suspected infection.Patient was last known to be in stable condition following the event.

• Brand Name: EQUINOXE
• Common Device Name: REVERSE 38MM HUMERAL CONST LINER +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10706597
• Report Number: 1038671-2020-00582
• Device Sequence Number: 11673838
• Product Code: KWT
• UDI-Device Identifier: 10885862283023
• UDI-Public: 10885862283023
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• 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): 10/20/2020

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 Expiration Date: 05/17/2019
• Device Model Number: 300-01-14
• Device Catalogue Number: 300-01-14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention