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

Model Number	300-01-12
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/11/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1038671-2022-00345
• Device Sequence Number: 5554509
• Product Code: KWT
• UDI-Device Identifier: 10885862283016
• UDI-Public: 10885862283016
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male