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

Model Number	320-46-00
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical device(s): 320-10-05, (b)(4) - equinoxe reverse tray adapter plate tray +5; 320-20-00, (b)(4) - eq reverse torque defining screw kit.
Event or Problem Description
As reported, approximately 9 months postop a right tsa, this (b)(6) y/o male patient was infected with covid 19 and admitted to icu.The patient was on ventilator for 2 weeks.When he was discharged from the hospital, he described his right shoulder as ¿not feeling right¿.Upon x-ray examine, the disassociated implants were evident.The patient was fine prior to having covid.The torque screw backed out and the tray and liner disassociated from the stem.A revision was completed with replacement of the torque screw, tray and liner.All parts or pieces were removed from the wound site.The patient underwent successful revision and replacement of failed implants and is doing well.Devices to be returned.
Additional Manufacturer Narrative
The revision reported was likely the result of either experiencing a traumatic event while being on a ventilator, incomplete seating of the torque defining screw during initial implantation due to cross-threading, or a combination of the two, which resulted in the torque defining screw backing out and subsequently the humeral tray disassociating from the humeral stem.

• Brand Name: EQUINOXE
• Common Device Name: REVERSE 46MM HUMERAL LINER +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10425487
• Report Number: 1038671-2020-00497
• Device Sequence Number: 19577040
• Product Code: KWT
• UDI-Device Identifier: 10885862086730
• UDI-Public: 10885862086730
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 12/16/2020

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 Expiration Date: 08/13/2024
• Device Model Number: 320-46-00
• Device Catalogue Number: 320-46-00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR