MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-38-03

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Subluxation (4525)

Event Date 07/17/2023

Event Type  Injury  

Event Description

As reported by the equinoxe shoulder study, the 70-year-old male patient had an initial left tsa on (b)(6) 2023 and presented with instability/subluxation, approximately 2 month(s) and 0 year(s) post-operatively on (b)(6) 2023.Patient reached over shoulder to buckle seatbelt on (b)(6) 23 and had a subluxation incident.Second subluxation occurred in (b)(6) 2023 after carrying a 10 lb box.The outcome of this event is considered continuing, and no action was taken.The case report form indicates that this event is possibly related to the device and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.

Manufacturer Narrative

(h3) pending evaluation (d10) concomitant device(s): 320-06-38 - glenosphere 38mm: a042835 300-30-07 - equinoxe preserve stem 7mm: a262915 320-10-00 - equinoxe reverse tray adapter plate tray +0: a488094 320-15-01 - eq rev glenoid plate: a273994 320-15-05 - eq rev locking screw: a375383 320-20-00 - eq reverse torque defining screw kit: a424139 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm: s424777 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm: a172579 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: a344721 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: s425113.

• Brand Name: EQUINOXE REVERSE 38MM HUMERAL LINER +2.5
• 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; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18791697
• MDR Text Key: 336397595
• Report Number: 1038671-2024-00330
• Device Sequence Number: 1
• Product Code: KWT
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-38-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2022
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 127 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White