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

Model Number	320-42-10
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	10/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 320-10-00, (b)(4), equinoxe reverse tray adapter plate tray +0.
Event or Problem Description
It was reported that the surgeon explanted a 42+0 constrained humeral liner that disassociated from the humeral adapter tray due to a dislocation of a reverse shoulder.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of a combination of the dislocation and the humeral liner disassociation.It is unclear if the dislocation allowed for the humeral liner to disassociate or if the humeral liner disassociation led to the dislocation, which may have been the result of bone impingement.(h6) evaluation codes: 1924, 2923.Section h11: the following sections have corrected information: (h1) type of reportable event: serious injury.

• 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: 9207743
• Report Number: 1038671-2019-00524
• Device Sequence Number: 13586630
• Product Code: KWT
• UDI-Device Identifier: 10885862086716
• UDI-Public: 10885862086716
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2020

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: 10/07/2019
• Supplement Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 06/18/2020
• 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
• Patient Age: 63 YR