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

Model Number	320-46-00
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant device(s): 300-30-06, equinoxe preserve stem 6mm.320-10-00, equinoxe reverse tray adapter plate tray +0.320-01-42, equinoxe reverse 42mm glenosphere.320-15-02, rs glenoid plate sup aug, 10 deg.
Event or Problem Description
As reported, this (b)(6) y/o male patient was reaching for something with his l arm in forward elevation and external rotation and sustained an instability event.Disassociation of polyethylene was diagnosed and the patient was revised.The case report form indicates this event is definitely related to devices or procedure.This event report was received through clinical data collection activities.
Additional Manufacturer Narrative
(d4) serial number: (b)(6), expiration date: 03-jul-2024.(h3) the revision reported was likely the result of either incomplete seating of the liner during the first revision, bone impingement, patient-related conditions, or any combination of these possibilities, which led to humeral liner disassociation.However, this cannot confirmed as the devices were not returned for evaluation and x-rays were not provided.(h4) device manufacture date: 08-jul-2019.Section h11: the following sections have corrected information: (d11) concomitant device(s): 320-10-00, 6254466 - equinoxe reverse tray adapter plate tray +0, 320-01-42, 6301886 - equinoxe reverse 42mm glenosphere, 320-15-05, 6344306 - eq rev locking screw, 320-20-00, 6337513 - eq reverse torque defining screw kit.

• Brand Name: EQUINOXE
• Common Device Name: REVERSE 46MM HUMERAL 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: 12431973
• Report Number: 1038671-2021-00462
• Device Sequence Number: 5360973
• Product Code: KWT
• UDI-Device Identifier: 10885862086730
• UDI-Public: 10885862086730
• 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: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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: 07/03/2024
• Device Model Number: 320-46-00
• Device Catalogue Number: 320-46-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2019
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White