MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; 36MM HUMERAL LINER +2.5MM UNCONSTRAINED

Model Number	320-36-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 instability and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.Concomitant device(s): 300-01-11, equinoxe, humeral stem primary, press fit 11mm, 320-10-05, equinoxe reverse tray adapter plate tray +5, 320-31-36, glenosphere, 36mm, 320-35-01, small glenoid plate.
Event or Problem Description
Approximately 9 mos postop a rtsa, this (b)(6) year old female patient felt subluxation and self reduced.The case report form from the clinical study database indicates this event is possibly related to devices and/or procedure.This event report was received through clinical data collection activities.Outcome reported as resolved on (b)(6) 2021.No other information was available.

• Brand Name: EQUINOXE
• Common Device Name: 36MM HUMERAL LINER +2.5MM UNCONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 12618869
• Report Number: 1038671-2021-00530
• Device Sequence Number: 16481352
• Product Code: KWT
• UDI-Device Identifier: 10885862086624
• UDI-Public: 10885862086624
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K093275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2021

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 Model Number: 320-36-03
• Device Catalogue Number: 320-36-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/12/2021
• 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
• Patient Age: 71 YR
• Patient Weight: 61