MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 38MM HUMERAL CONST LINER +2.5

Model Number	320-38-13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(device evaluated by mfr) pending evaluation.(concomitant medical products) concomitant device(s): 321-20-00, (b)(4), equinoxe reverse shoulder drill kit.320-15-05, (b)(4), eq rev locking screw.320-15-03, (b)(4), rs glenoid plate post aug, 8 deg, left.320-01-38, (b)(4), equinoxe reverse 38mm glenosphere.320-20-38, (b)(4), eq rev compress screw lck cap kit, 4.5 x 38mm.320-20-30, (b)(4), eq rev compress screw lck cap kit, 4.5 x 30mm.320-20-18, (b)(4), eq rev compress screw lck cap kit, 4.5 x 18mm.320-20-18, (b)(4), eq rev compress screw lck cap kit, 4.5 x 18mm.306-01-08, (b)(4), equinoxe, humeral long stem 8mm 175mm.320-20-00, (b)(4), eq reverse torque defining screw kit.320-10-00, (b)(4), equinoxe reverse tray adapter plate tray +0.
Event or Problem Description
As reported, this (b)(6) y/o female patient was experiencing instability of the left shoulder which was approximately 13 months prior.A revision was scheduled due to instability / dislocation issue with the patient.The humeral tray, torque screw and liner was changed in the patient.Implants were removed and replaced.Patient left or stable.Explants will not be returned per hospital policy.Patient was last known to be in stable condition following the event.
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.

• Brand Name: EQUINOXE
• Common Device Name: REVERSE 38MM HUMERAL CONST LINER +2.5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10730472
• Report Number: 1038671-2020-00588
• Device Sequence Number: 11182325
• Product Code: KWT
• UDI-Device Identifier: 10885862086686
• UDI-Public: 10885862086686
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 12/16/2020

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: 04/22/2025
• Device Model Number: 320-38-13
• Device Catalogue Number: 320-38-13
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 12/16/2020
• 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
• Patient Age: 64 YR