MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER

Model Number EQUINOXE REVERSE 38MM HUMERAL LINER +0

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Joint Dislocation (2374)

Event Date 09/20/2022

Event Type  Injury  

Event Description

It was reported that a male patient, initial left shoulder implanted on (b)(6) 2022, dislocated post-surgery and was revised on (b)(6) 2022.The zero liner was replaced with a 38mm constrained liner.New glenosphere screw was used as glenosphere was removed for access.The patient was last known to be in stable condition following the event.No devices are returning as the hospital discarded them.

Manufacturer Narrative

No device return anticipated as the hospital discarded them.Concomitant medical products: 2004322319 a10012 - gps implant kit v2, 6124050 308-05-22 - distal fixation ring ha 22.5, 6472353 308-10-50 - 50mm middle segment modular, 6699356 308-09-00 - small prox body +0, 6997778 320-01-38 - equinoxe reverse 38mm glenosphere, 7022568 308-15-50 - taper locking screw 50, 7026732 308-02-09 - 9x120mm distal stem modular cemented, a007912 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, a112789 320-15-05 - eq rev locking screw, a116220 531-78-20 - shouldr gps hex pins kit, a119490 320-15-01 - eq rev glenoid plate, a125134 320-20-00 - eq reverse torque defining screw kit, a127564 320-10-00 - equinoxe reverse tray adapter plate tray +0, s359954 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm, s365063 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, s375498 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, s375500 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the dislocation and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: EQUINOXE
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15627331
• MDR Text Key: 302005179
• Report Number: 1038671-2022-01321
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086655
• UDI-Public: 10885862086655
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE 38MM HUMERAL LINER +0
• Device Catalogue Number: 320-38-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2022
• Date Device Manufactured: 06/30/2022
• 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 Outcome(s): Required Intervention
• Patient Sex: Male