MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; 36MM HUMERAL LINER +0 UNCONSTRAINED

Model Number	320-36-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	07/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 320-31-40, 6707690 - glenosphere, 40mm.
Event or Problem Description
As reported, this (b)(6) y/o female patient had a proximal humeral fracture and received a reverse l tsa on/near (b)(6) 2021.An i&d was being performed with the plan to change the humeral liner, glenosphere, humeral tray then wash out the wound and re-implant new implants of the same taken out.When re-implanting, there was a 36 liner implanted along with a 40mm glenosphere.Subsequently taken to the or on (b)(6) 2021 for an i&d.Another surgery was performed this morning ((b)(6) 2021) to exchange the 36 humeral liner for a 40mm humeral liner.This was uneventful.The humeral liner will return; however, the glenosphere is disposed by hospital.
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 the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.Section h11: *the following sections have corrected information: (section f10) please disregard health effect - impact codes.These were entered in error.

• Brand Name: EQUINOXE
• Common Device Name: 36MM HUMERAL LINER +0 UNCONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 12251977
• Report Number: 1038671-2021-00364
• Device Sequence Number: 4742916
• Product Code: KWT
• UDI-Device Identifier: 10885862086617
• UDI-Public: 10885862086617
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K093275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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: 05/10/2026
• Device Model Number: 320-36-00
• Device Catalogue Number: 320-36-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female