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

Model Number 320-46-00

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/07/2020

Event Type  Injury  

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 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.

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
• Type of Device: REVERSE 46MM HUMERAL LINER +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10425487
• MDR Text Key: 203491468
• Report Number: 1038671-2020-00497
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086730
• UDI-Public: 10885862086730
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-46-00
• Device Catalogue Number: 320-46-00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR