MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 46MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-46-00

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 11/19/2022

Event Type  Injury  

Event Description

As reported by the equinoxe shoulder study, the 58-year-old male patient had a right tsa on (b)(6) 2022.The patient presented with disassociation of polyethylene - patient has experienced chronic instability of the shoulder since pod2, then in one subluxation event, the polyethylene dissociated.The outcome of this event is considered resolved and the report indicates that the action taken is revision on (b)(6) 2024.The case report form indicates that this event is definitely 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): 300-30-06 - equinoxe preserve stem 6mm: (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0: (b)(6).320-10-46 - glenosphere 46x21mm inset: (b)(6).320-15-04 - rs glenoid plate r post aug, 8 deg, right: (b)(6).320-15-05 - eq rev locking screw: (b)(6).320-20-00 - eq reverse torque defining screw kit: (b)(6).320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm: (b)(6).320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm: (b)(6).320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm: (b)(6).(h3) pending evaluation.

• Brand Name: EQUINOXE REVERSE 46MM 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; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18909371
• MDR Text Key: 337729234
• Report Number: 1038671-2024-00513
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086730
• UDI-Public: 10885862086730
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-46-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/05/2022
• 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
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White