MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 46MM HUMERAL CONST LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-46-13

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 08/11/2022

Event Type  Injury  

Event Description

As reported by the equinoxe shoulder study, the 63-year-old male patient had a left tsa on (b)(6) 2022.The patient presented with a instability / subluxation on (b)(6) 2022.Patient woke up from sleeping with his shoulder dislocated.This event is related to case (b)(6), sp106l-rev1, case (b)(6) , sp106l-rev2, and case (b)(6) , sp106l-rev4.The outcome of this event is considered resolved on (b)(6) 2022 by the action of revision - revised to hemi.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

(d10) concomitant device(s): 320-01-46 - equinoxe reverse 46mm glenosphere: 7097332 320-15-05 - eq rev locking screw: 7312793 (h3) pending evaluation.

• Brand Name: EQUINOXE REVERSE 46MM HUMERAL CONST 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: matt collins ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19009219
• MDR Text Key: 338979709
• Report Number: 1038671-2024-00692
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086761
• UDI-Public: 10885862086761
• 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: 03/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2022
• Device Catalogue Number: 320-46-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/14/2017
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Race: White