MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 46MM HUMERAL LINER +2.5

Model Number	320-46-03
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 320-01-46, (b)(4), equinoxe reverse 46mm glenosphere.320-15-03, (b)(4), rs glenoid plate l post aug.8 deg, left, 300-30-11, (b)(4), equinoxe preserve stem 11mm.320-15-05, (b)(4), eq rev locking screw.320-10-00, (b)(4), equinoxe reverse tray adapter plate tray +0.320-46-03, (b)(4), equinoxe reverse 46mm humeral liner +2.5.320-20-00, (b)(4), eq reverse torque defining screw kit.
Event or Problem Description
As reported, approximately 1.5 years post op initial left tsa, this (b)(6) patient was revised due to dislocation of joint which lead to dislodging of the poly.Patient was last known to be in stable condition following the event.Devices will not be retuning due to the hospital disposing of them.
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 either incomplete seating of the liner during implantation, bone impingement, patient conditions, or a combination of these possibilities.However, this cannot be confirmed as the devices were not available for evaluation and x-ray images were not provided.

• Brand Name: EQUINOXE
• Common Device Name: REVERSE 46MM HUMERAL LINER +2.5
• 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: 13710692
• Report Number: 1038671-2022-00244
• Device Sequence Number: 12124561
• Product Code: KWT
• UDI-Device Identifier: 10885862086747
• UDI-Public: 10885862086747
• 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: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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: 08/11/2024
• Device Model Number: 320-46-03
• Device Catalogue Number: 320-46-03
• 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: 02/14/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2019
• 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: Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male