MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-10-00

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 10/03/2023

Event Type  Injury  

Event Description

As reported, approximately 7 months post op initial left tsa, this 65 y/o male patient was revised due to multiple atraumatic dislocations.The humeral liner, humeral tray, & reverse torque screw were removed.The surgeon built up the humeral side to achieve stability using a +10mm humeral tray & +0mm humeral liner.Patient was last known to be in stable condition following the event.Product not returning - facility policy.

Manufacturer Narrative

Section h10: (h3) pending evaluation.(d10) concomitant device(s): (b)(6), 300-01-11 - equinoxe, humeral stem primary, press fit 11mm.(b)(6), 320-06-38 - glenosphere 38mm.(b)(6), 320-15-01 - eq rev glenoid plate.(b)(6), 320-15-05 - eq rev locking screw.(b)(6), 320-20-00 - eq reverse torque defining screw kit.(b)(6), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(6), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6), 320-38-03 - 145-deg pe 38mm hum liner +2.5.

• Brand Name: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0
• 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: 17985416
• MDR Text Key: 326272152
• Report Number: 1038671-2023-02585
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086419
• UDI-Public: 10885862086419
• 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
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-10-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/24/2023
• 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
• Treatment: SEE H10
• Patient Age: 65 YR
• Patient Sex: Male