MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-38-00

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/13/2023

Event Type  Injury  

Event Description

As reported, 17 days post op initial left tsa, this 71 y/o female patient was revised.It was revised for dislocation due to the greater tuberosity fracturing off.The patient was revised with a 38mm humeral liner.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Unable to obtain photos/x-rays.Product not returning - disposed at hospital.

Manufacturer Narrative

Section h10: (h3) pending evaluation (d10) concomitant device(s): (b)(6) 300-01-13 - equinoxe, humeral stem primary, press fit 13mm.(b)(6) 320-01-38 - equinoxe reverse 38mm glenosphere.(b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0.(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) 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6) 531-20-00 - shldr gps rvrs drill kit.(b)(6) 531-78-20 - shouldr gps hex pins kit.4000123053, (b)(6) - gps implant kit v2.

• Brand Name: EQUINOXE REVERSE 38MM HUMERAL LINER +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: 18135744
• MDR Text Key: 328108614
• Report Number: 1038671-2023-02775
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086655
• UDI-Public: 10885862086655
• 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: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-38-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/14/2023
• 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
• Patient Age: 71 YR
• Patient Sex: Female