MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 42MM HUMERAL CONST LINER +0

Model Number	320-42-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation: concomitant device(s): lateralized 42 glenosphere (320-02-42, (b)(4)); glenosphere locking screw (320-15-05, (b)(4)); reverse locking torque screw (320-11-00, (b)(4)); 34mm bone screw (320-20-34, (b)(4)); humeral tray (320-10-00, (b)(4)).
Event or Problem Description
As reported, the patient had failure of a reverse total shoulder due to dislocation.Revision replaced the humeral liner and glenosphere, along with the associated locking screws.Patient was stable upon leaving the or and there was not a delay to surgery.Devices not returning due to hospital policy.
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 dislocation and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition and history of falls.Section h11: the following sections have corrected information: (b5) describe event or problem: as reported, the elderly and skinny male patient had failure of a reverse total shoulder due to dislocation.The initial implant date is unknown.This patient has a history of falling and dislocating his shoulder.Revision replaced the humeral liner and glenosphere, along with the associated locking screws.Patient was stable upon leaving the or and there was not a delay to surgery.Devices not returning due to hospital policy.
Event or Problem Description
As reported, the elderly and skinny male patient had failure of a reverse total shoulder due to dislocation.The initial implant date is unknown.This patient has a history of falling and dislocating his shoulder.Revision replaced the humeral liner and glenosphere, along with the associated locking screws.Patient was stable upon leaving the or and there was not a delay to surgery.Devices not returning due to hospital policy.

• Brand Name: EQUINOXE
• Common Device Name: REVERSE 42MM HUMERAL CONST LINER +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9769066
• Report Number: 1038671-2020-00225
• Device Sequence Number: 3153586
• Product Code: KWT
• UDI-Device Identifier: 10885862086716
• UDI-Public: 10885862086716
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/11/2020

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 Model Number: 320-42-10
• Device Catalogue Number: 320-42-10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 09/11/2020
• 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: UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention