MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 6MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 300-30-06

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

Patient Problem Bone Fracture(s) (1870)

Event Date 01/24/2024

Event Type  Injury  

Manufacturer Narrative

(d10) concomitant device(s): 320-38-00 - 145-deg pe 38mm hum liner +0: a550004 320-10-00 - equinoxe reverse tray adapter plate tray +0: a285236 320-06-38 - glenosphere 38mm: a860948 320-15-07 - sup/post aug plate, l rs glenoid baseplate: a826082 315-35-00 - glnd kwire: a585081 315-35-00 - glnd kwire: a820684 320-15-05 - eq rev locking screw: a603142 320-20-00 - eq reverse torque defining screw kit: a855998 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm: s509134 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: s502520 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: s502614 521-78-31 - threaded pin size 2.6 collarless 2pk: s503241 531-55-88 - ergo gps 3.2mm drill kit sterile: a762816 (h3) pending evaluation.

Event Description

As reported by the equinoxe shoulder study, the 76-year-old female patient had a left tsa on (b)(6) 2024 and presented with humeral fracture - midshaft, intra-operatively on (b)(6) 2024.Intra-op humeral calcar fracture during reduction.The outcome of this event is considered continuing, with the action taken of other - cerclage cable around humerus.The case report form indicates that this event is unlikely related to the device and definitely related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.

• Brand Name: EQUINOXE PRESERVE STEM 6MM
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 18833091
• MDR Text Key: 336853479
• Report Number: 1038671-2024-00387
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10885862515742
• UDI-Public: 10885862515742
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162726
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 300-30-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/07/2023
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American