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 03/09/2022

Event Type  Injury  

Event Description

As reported, approximately 3 years post op the initial left tsa, this (b)(6) male patient's was revised due a painful shoulder with radiographic loose stem.Humeral liner had disassociated, creating metallosis and osteolysis.All implants were removed.There was not delay.Patient was last known to be in stable condition following the event.Devices will not be retuning, hospital disposed of implants.

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 320-15-04, (b)(4) - rs glenoid plate post aug, 8 deg, right, 320-15-05, (b)(4) - eq rev locking screw, 320-01-42, (b)(4) - equinoxe reverse 42mm glenosphere, 320-10-00, (b)(4) - equinoxe reverse tray adapter plate tray +0, 320-20-00, (b)(4) - eq reverse torque defining screw kit, 320-42-03, (b)(4) - equinoxe reverse 42mm humeral liner +2.5,and 320-42-00, (b)(4) - equinoxe reverse 42mm humeral liner +0.

Manufacturer Narrative

Section h10: (h3) the revision reported was likely the result of both aseptic (non-infected) humeral loosening and humeral liner disassociation, which led to the reported metallosis and osteolysis.The humeral loosening may have been the result of an insufficient bond between the humeral stem and the bone.The humeral liner disassociation may have been the result of incomplete seating of the liner during implantation, bone impingement, patient-related conditions, or any combination of these possibilities.However, this cannot be confirmed as the devices were not returned for evaluation and pre-revision x-rays were unable to be obtained.Section h11: the following sections have corrected information: (h6) component code: 22, known inherent risk of device.

• 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: 13937933
• MDR Text Key: 288095982
• Report Number: 1038671-2022-00301
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• 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: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2018
• 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: SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 91 YR
• Patient Sex: Male