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

Model Number EQUINOXE REVERSE 46MM HUMERAL LINER +0

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 01/12/2023

Event Type  Injury  

Event Description

As reported, approximately three years post initial left side tsa, the 56 y/o male patient had a revision due to poly disassociation.Patient was revised to arthrex devices.There were parts/fragments that fell into patient and were removed.The event did not lead to surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images and x-rays received.The device is available for evaluation.

Manufacturer Narrative

Concomitant medical products: equinoxe humeral stem primary press fit 12mm (cat# 300-01-12 / serial# (b)(4)).Equinoxe reverse 46mm glenosphere (cat# 320-01-46 / serial# (b)(4)).Equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / serial# (b)(4)).Eq rev glenoid plate (cat# 320-15-01 / serial# (b)(4)).Eq rev locking screw (cat#320-15-05 / serial# (b)(4)).Eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(4)).Eq rev compress screw lck cap kit, 4.5 x 42mm (cat# 320-20-42 / serial# (b)(4)).Eq rev compress screw lck cap kit, 4.5 x 46mm (cat# 320-20-46 / serial# (b)(4)).Eq rev compress screw lck cap kit, 4.5 x 46mm (cat# 320-20-46 / serial# (b)(4)).Equinoxe reverse shoulder drill kit (cat# 321-20-00 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Manufacturer Narrative

After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported may have been the result of incomplete seating of the liner during implantation, bone impingement, patient-related conditions, an unreported post traumatic event, or any combination of these possibilities, which led to humeral liner disassociation.However, this cannot be confirmed as the devices were not returned for evaluation.The most probable root cause associated with the reported event of ¿humeral liner disassociation¿ is associated with post-operative disassociation of the humeral liner component from the humeral adapter tray/plate.Do not use for humeral liner seating difficulty.

• 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16264578
• MDR Text Key: 308377640
• Report Number: 1038671-2023-00079
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE 46MM HUMERAL LINER +0
• Device Catalogue Number: 320-46-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2019
• 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 Age: 56 YR
• Patient Sex: Male