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

Model Number EQUINOXE REVERSE 38MM HUMERAL LINER +0

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/01/2023

Event Type  Injury  

Event Description

As reported, the patient had an initial right tsa on (b)(6) 2018.The patient presented with acromial fracture.The case report form indicates that this event is possibly related to device, definitely related to procedure.Outcome: resolved on (b)(6) 2018.

Manufacturer Narrative

Pending investigation.D10: serial number item number and full description (b)(6), 300-01-09 - equinoxe, humeral stem primary, press fit 9mm.(b)(6), 300-01-09 - equinoxe, humeral stem primary, press fit 9mm.(b)(6), 320-01-38 - equinoxe reverse 38mm glenosphere.(b)(6), 320-01-38 - equinoxe reverse 38mm glenosphere.(b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6), 320-15-01 - eq rev glenoid plate.(b)(6), 320-15-01 - eq rev glenoid plate.(b)(6), 320-38-00 - equinoxe reverse 38mm humeral liner +0.(b)(6), 320-38-00 - equinoxe reverse 38mm humeral liner +0.

• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17842253
• MDR Text Key: 324558256
• Report Number: 1038671-2023-02402
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086655
• UDI-Public: 10885862086655
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: EQUINOXE REVERSE 38MM HUMERAL LINER +0
• Device Catalogue Number: 320-38-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Race: White