MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 11/24/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products:¿ 1.5mm replicator plate cat# 300-10-15 / serial(b)(4); humeral head short 47mm x 18mm cat# 310-01-47 / serial(b)(4); torque def screw kit cat# 300-20-02 / serial(b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, approximately two months post initial left tsa, the 65 y/o male patient presented with infection.On inspection the surgeon decided to extract three (3) components and replace them.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

(h3) it was reported that a 65 yo male presented for infection of a left total shoulder arthroplasty.On inspection the surgeon decided to extract 3 components and replace them.Implant (b)(6) 2022 and revision (b)(6) 2022; revised to exactech devices.There were no issues during the revision procedure.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.The devices will be returned; disposed of by hospital.No additional information.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 surgical revision for infection cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• 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: 16072861
• MDR Text Key: 306405450
• Report Number: 1038671-2022-01646
• 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: 02/06/2023

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 Model Number: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• Device Catalogue Number: 300-01-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 01/17/2023
• Supplement Dates FDA Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2019
• 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: CAGE GLENOID LEFT
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male