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

Model Number	320-38-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by manufacturer? pending evaluation.Concomitant medical device(s): 320-10-00, (b)(4) - equinoxe reverse tray adapter plate tray +0; 320-20-00, (b)(4) - eq reverse torque defining screw kit; 320-02-38, (b)(4) - rs expanded glenosphere 38mm, +4mm offset; 320-15-05, (b)(4) - eq rev locking screw.
Event or Problem Description
As reported, approximately 8 months after the initial implant, this male patient' right shoulder was revised due to instability.The patient was last known to be in stable condition following the event.Devices will not return due the hospital disposing them.
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 instability 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: (b5) as reported, approximately 8 months after the initial implant, this male patient experienced instability of right shoulder.During a revision, the surgeon upsized the components.Instability occurred over time.Patient was last known to be in stable condition following the event.Devices not returning due to facility policy.
Event or Problem Description
As reported, approximately 8 months after the initial implant, this male patient experienced instability of right shoulder.During a revision, the surgeon upsized the components.Instability occurred over time.Patient was last known to be in stable condition following the event.Devices not returning due to facility policy.

• 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: 10257072
• Report Number: 1038671-2020-00331
• Device Sequence Number: 2624184
• Product Code: KWT
• UDI-Device Identifier: 10885862086679
• UDI-Public: 10885862086679
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2020

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: 06/16/2024
• Device Model Number: 320-38-10
• Device Catalogue Number: 320-38-10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 11/03/2020
• 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