MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 46MM HUMERAL CONST LINER +0

Model Number	320-46-10
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by manufacturer? pending evaluation: concomitant medical device(s): 320-01-46, (b)(4) - eq rev 46mm glenosphere; 320-10-05, (b)(4) - eq rev adapter plate tray +5; 320-15-05, (b)(4) - eq rev locking screw; 320-20-00, (b)(4) - eq rev torque screw kit.
Event or Problem Description
As reported approximately 22 months postop the initial ltsa this (b)(6) y/o male patient reached down to pull up a kickstand on his motorcycle and felt a pop.He was revised to the following, downsizing from 46mm to 42mm.Patient was last known to be in stable condition following the event.Device will not return due to facility policy.
Additional Manufacturer Narrative
(h3) the revision reported may have been the result of either incomplete seating of the liner during implantation, bone impingement, patient-related conditions, post-traumatic event, or any combination of these possibilities, which led to humeral liner disassociation.However, this cannot be confirmed as the devices were not returned for evaluation and x-rays were not provided.

• Brand Name: EQUINOXE
• Common Device Name: REVERSE 46MM HUMERAL CONST LINER +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 12770117
• Report Number: 1038671-2021-00589
• Device Sequence Number: 3144532
• Product Code: KWT
• UDI-Device Identifier: 10885862086754
• UDI-Public: 10885862086754
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2022

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: 09/24/2022
• Device Model Number: 320-46-10
• Device Catalogue Number: 320-46-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male