MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 300-01-11

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/17/2024

Event Type  Injury  

Manufacturer Narrative

(d10) concomitant device(s): 320-36-03 - 145-deg pe 36mm hum liner +2.5: (b)(6) ; 320-10-00 - equinoxe reverse tray adapter plate tray +0: (b)(6) ; 320-31-36 - glenosphere, 36mm: (b)(6) ; 320-35-03 - small posterior augment glenoid plate, left: (b)(6) ; 315-35-00 - glnd kwire: (b)(6) ; 319-01-32 - steinmann pin sterile 3.2mm x 178mm: (b)(6) ; 320-15-05 - eq rev locking screw: (b)(6) ; 320-20-00 - eq reverse torque defining screw kit: (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); 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: (b)(6); 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm: (b)(6); 521-78-32 - threaded pin size 3.0 collarless 2pk: (b)(6); 531-78-20 - shouldr gps hex pins kit: (b)(6).(h3) pending evaluation.

Event Description

As reported by the equinoxe shoulder study, the 64-year-old male patient had a left tsa on (b)(6) 2024.The patient presented with a humeral fracture, intra-operatively on (b)(6)2024.Greater tuberosity fracture during the case.Bone was extremely osteoporotic.Had to use standard and cemented stem and convert to rtsa due to osteoporosis.The outcome of this event is considered continuing and the action taken was other - cerclage sutures around tuberosity at surgery.The case report form indicates that this event is definitely not related to the device and unlikely related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• Type of Device: PROSTHESIS, SHOULDER, SEMI-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: 18950558
• MDR Text Key: 338253535
• Report Number: 1038671-2024-00620
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042021
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 300-01-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/11/2021
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White