MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL STEM PRIMARY, PRESS FIT 11MM

Model Number 300-01-11

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

Patient Problem Failure of Implant (1924)

Event Date 11/25/2021

Event Type  Injury  

Event Description

As reported, approximately 3.5 years post op initial tsa, this (b)(6) patient was experiencing pain due to ascetic humeral loosening seem on x-rays.Patient was offered revision surgery, but declined at this stage.Patient wants to wait.The case report form indicates this event is possibly related to devices and/or procedure.This event report was received through clinical data collection activities.

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 310-01-50 - equinoxe, humeral head short, 50mm (beta), 300-10-15 - equinoxe replicator plate 1.5mm o/s, and 314-02-14 - equinoxe glenoid, pegged beta, large.

Manufacturer Narrative

Section h10: (h3) the humeral loosening and pain reported may have been the result of an insufficient bond between the humeral stem and the bone.However, this cannot be confirmed as x-rays were not provided and the devices were not available for evaluation due to the patient declining revision surgery.

• Brand Name: EQUINOXE
• Type of Device: HUMERAL STEM PRIMARY, PRESS FIT 11MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 13693511
• MDR Text Key: 286771096
• Report Number: 1038671-2022-00234
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 300-01-11
• Device Catalogue Number: 300-01-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White