MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 42MM HUMERAL LINER +0

Model Number 320-42-00

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Discomfort (2330)

Event Date 10/16/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant medical device(s): 320-10-00, (b)(4), equinoxe reverse tray adapter plate tray +0; 320-01-42, (b)(4), equinoxe reverse 42mm glenosphere.

Event Description

It was reported that the primary surgery date was (b)(6) 2017.Patient works away on oil rigs and has to have annual fitness medicals.The patient had to jump into the sea to demonstrate his ability to swim, after doing the fitness medical patient noticed marked discomfort in his right shoulder.The surgeon chose to re-open the patient¿s shoulder as he believed there had been wear to the liner.It was clear when open that the liner had become lose and moved away from the adapter tray causing the liner to begin to wear away.The surgeon removed the liner, adapter tray and glenosphere as they all showed noticeable evidence of wear.

Manufacturer Narrative

H10: section h10: (h3) the revision reported was likely the result of patient's above average physical activity level involving participating in fitness medicals that required him to jump into the sea, which may have caused bone impingement and/or extreme wear of the humeral liner, and resulted in the humeral liner disassociating from the humeral tray.However, this cannot be confirmed as the explanted devices were not available for evaluation.

• Brand Name: EQUINOXE
• Type of Device: REVERSE 42MM HUMERAL LINER +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9262620
• MDR Text Key: 164497907
• Report Number: 1038671-2019-00549
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• 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: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2022
• Device Model Number: 320-42-00
• Device Catalogue Number: 320-42-00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention