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

Model Number 320-46-10

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 10/15/2021

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer? pending evaluation: concomitant medical device(s): 320-01-46, (b)(4) - eq rev 46mm glenosphere; 320-10-05, (b)(4) - eq rev adapter plate tray +5; 320-15-05, (b)(4) - eq rev locking screw; 320-20-00, (b)(4) - eq rev torque screw kit.

Event Description

As reported approximately 22 months postop the initial ltsa this (b)(6) y/o male patient reached down to pull up a kickstand on his motorcycle and felt a pop.He was revised to the following, downsizing from 46mm to 42mm.Patient was last known to be in stable condition following the event.Device will not return due to facility policy.

Manufacturer Narrative

(h3) the revision reported may have been the result of either incomplete seating of the liner during implantation, bone impingement, patient-related conditions, post-traumatic event, or any combination of these possibilities, which led to humeral liner disassociation.However, this cannot be confirmed as the devices were not returned for evaluation and x-rays were not provided.

• Brand Name: EQUINOXE
• Type of Device: REVERSE 46MM HUMERAL CONST 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: 12770117
• MDR Text Key: 281915126
• Report Number: 1038671-2021-00589
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086754
• UDI-Public: 10885862086754
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2022
• Device Model Number: 320-46-10
• Device Catalogue Number: 320-46-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male