MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 11/30/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant products: equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / serial# (b)(4), eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(4), equinoxe reverse 46mm humeral liner +0 (cat# 320-46-00 / serial# (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, approximately 3.5 years post initial right-side tsa, the 59 y/o male patient had a revision procedure due to loosening.The glenoid components left, and humeral components replaced.There was no breakage of device and there was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain x-rays and photos.The device is not available for evaluation as they were disposed by the hospital.

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 an insufficient bond between the humeral stem and the bone, which led to aseptic (non-infected) humeral loosening.However, this cannot be confirmed as the devices were not available for evaluation and radiographs were unable to be obtained.The most probable root cause associated with the reported event of ¿loosening - humeral¿ is associated with weakened integration of the humeral component at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM
• 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: 16074692
• MDR Text Key: 306407079
• Report Number: 1038671-2022-01647
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM
• Device Catalogue Number: 300-01-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2019
• 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
• Treatment: EQ REV LOCKING SCREW; EQUINOXE REVERSE 46MM GLENOSPHERE; RS GLENOID PLATE POST AUG, 8 DEG, RIGHT
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male