MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 42MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-42-00

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Joint Dislocation (2374)

Event Date 05/03/2023

Event Type  Injury  

Manufacturer Narrative

(d10) concomitant device(s): 300-01-13 - equinoxe, humeral stem primary, press fit 13mm : 6613063 320-02-42 - rs expanded glenosphere 42mm, +4mm offset : 6669891 320-10-00 - equinoxe reverse tray adapter plate tray +0 : 6728154 320-15-01 - eq rev glenoid plate : 6588671 320-15-05 - eq rev locking screw : 6683013 320-20-00 - eq reverse torque defining screw kit : 6687524 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm : s083862 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm : s086662 320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm : s094873 321-20-00 - equinoxe reverse shoulder drill kit : 6714598.(h3) pending evaluation.

Event Description

As reported by the equinoxe shoulder study, the 63-year-old white male had a left tsa (b)(6) 2020.The patient present with dislocation on (b)(6) 2023.The patient dislocated his prosthesis moving a chair.The action taken was other ¿ gave exercises and the outcome of this event is considered continuing.The case report form indicates that this event is definitely not 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.

Event Description

As reported by the equinoxe shoulder study, the 63-year-old white male had a left tsa implanted on (b)(6) 2020 and present with dislocation on (b)(6) 2023.The patient dislocated his prosthesis moving a chair.The patient was given exercises and then underwent standard reverse revision surgery on (b)(6) 2024, in which the torque screw, humeral tray, humeral liner, glenosphere, and glenosphere locking screw components were removed.The outcome of this event is now considered resolved and the case report form indicates that this event is definitely not 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

After further review of additional information received the following sections b5, d6b, g1, g3, g6, h1, h2, h3 and h6 have been updated accordingly.

• Brand Name: EQUINOXE REVERSE 42MM 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: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19213889
• MDR Text Key: 341399746
• Report Number: 1038671-2024-01013
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/09/2024

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: 320-42-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 05/04/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1422-2024
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White