MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM GLENOSPHERE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE REVERSE 38MM GLENOSPHERE

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 10/06/2023

Event Type  Injury  

Manufacturer Narrative

Section h10: (h3) pending evaluation (d10) concomitant device(s): (b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6) 320-15-05 - eq rev locking screw.(b)(6) 320-20-00 - eq reverse torque defining screw kit.(b)(6) 320-38-13 - equinoxe reverse 38mm humeral const liner +2.5.

Event Description

As reported, approximately 2 month post op initial right tsa, this male patient was revised due to dislocation.The surgeon has exchanged glenosphere, glenosphere locking screw, humeral tray, torque screw and humeral liner.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Product not returning - discarded at hospital.

• Brand Name: EQUINOXE REVERSE 38MM GLENOSPHERE
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• 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 ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18022857
• MDR Text Key: 326749622
• Report Number: 1038671-2023-02619
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086389
• UDI-Public: 10885862086389
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE 38MM GLENOSPHERE
• Device Catalogue Number: 320-01-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/13/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Sex: Male