MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL STEM PRIMARY PRESS FIT 12MM

Model Number 300-01-12

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

Patient Problem Failure of Implant (1924)

Event Date 03/11/2022

Event Type  Injury  

Event Description

As reported, approximately 3.5 years post op initial right tsa, this (b)(6) y/o male patient was revised due to increasing persistent pain in operative shoulder.Surgeon expressed concern that the humeral stem was loose.Intraoperatively, the stem was found to have some slight movement.There was no significant sign of infection but cultures were taken.All humeral components were removed & revised.The humeral stem was cemented this time.Patient was last known to be in stable condition following the event.Devices were kept by hospital.

Manufacturer Narrative

Concomitant device(s): 320-10-00 - equinoxe reverse tray adapter plate tray +0, 320-38-10 - equinoxe reverse 38mm humeral const liner +0, 320-20-00 - eq reverse torque defining screw kit.

Event Description

As reported, approximately 3.5 years post op initial right tsa, this 74 y/o male patient was revised due to increasing persistent pain in operative shoulder.Surgeon expressed concern that the humeral stem was loose.Intraoperatively, the stem was found to have some slight movement.There was no significant sign of infection but cultures were taken.All humeral components were removed & revised.The humeral stem was cemented this time.Patient was last known to be in stable condition following the event.Devices were kept by hospital due to concern of infection.

Manufacturer Narrative

Section h10: (h3) the revision reported in (b)(4) was likely the result of an insufficient bond between the humeral stem and the bone, which led to aseptic (non-infected) humeral loosening and pain.However, this cannot be confirmed as the devices were not available for evaluation.Section h11: the following sections have corrected information: (b5) describe event or problem: as reported, approximately 3.5 years post op initial right tsa, this 74 y/o male patient was revised due to increasing persistent pain in operative shoulder.Surgeon expressed concern that the humeral stem was loose.Intraoperatively, the stem was found to have some slight movement.There was no significant sign of infection but cultures were taken.All humeral components were removed & revised.The humeral stem was cemented this time.Patient was last known to be in stable condition following the event.Devices were kept by hospital due to concern of infection.(d4) serial number: (b)(6), expiration date: 31-may-2028, unique identifier (udi) #: (b)(4).(h4) device manufacture date: 04-jun-2018.(h6) component code: 4755, part/component/sub-assembly term not applicable.

• Brand Name: EQUINOXE
• Type of Device: HUMERAL STEM PRIMARY PRESS FIT 12MM
• 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: 13976733
• MDR Text Key: 288381613
• Report Number: 1038671-2022-00345
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862283016
• UDI-Public: 10885862283016
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 300-01-12
• Device Catalogue Number: 300-01-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2018
• 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: 74 YR
• Patient Sex: Male