MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 10MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	EQUINOXE REVERSE 38MM HUMERAL LINER +2.5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Unspecified Infection (1930); Medical device site infection (4845)
Date of Event	09/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient.Initial left shoulder implanted on (b)(6) 2018, underwent a revision procedure on september 28, 2023, approximately 5 years 7 months post the initial procedure.The patient had aseptic loosening of the humeral stem.The surgeon cemented in a size 10 primary humeral stem with +15 humeral tray.No device images or x-rays provided.There were no surgical delays or device breakages reported.The patient was last known to be in stable condition following the event.The explanted devices are not available for return as the surgeon wanted them.No further information.
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 300-01-10 - equinoxe humeral stem primary press fit 10mm.(b)(6) 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.(b)(6) 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6) 320-20-00 - eq reverse torque defining screw kit.(b)(6) 320-15-01 - eq rev glenoid plate.(b)(6) 320-01-38 - equinoxe reverse 38mm glenosphere.(b)(6) 320-15-05 - eq rev locking screw.(b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
The revision reported may be the result of the humeral stem septic loosening as reported.However, the loosening cannot be confirmed and any potential contributions from user or patient-related contributing factors to the event cannot be evaluated as no radiograph, images, or clinical information was provided.The reason for the infection cannot be conclusively determined; however, it may be related to an underlying patient condition and/or the surgical procedure.A review of the sterile certificate for all explanted components was performed and the sterile lots were accepted to the requirements.D1: corrected.D4: corrected.G4: corrected.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 10MM
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: geoff gannon ; gainesville 32653 ; 3523771140
• MDR Report Key: 17926247
• Report Number: 1038671-2023-02523
• Device Sequence Number: 19576010
• Product Code: HSD
• UDI-Device Identifier: 10885862283009
• UDI-Public: 10885862283009
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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: EQUINOXE REVERSE 38MM HUMERAL LINER +2.5
• Device Catalogue Number: 300-01-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 06/23/2025
• Date Device Manufactured: 12/27/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female