MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 14MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	300-01-14
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10): concomitant device(s): 320-46-00 - 145-deg pe 46mm hum liner +0: (b)(6).320-10-05 - equinoxe reverse tray adapter plate tray +5: (b)(6).320-08-46 - glenosphere exp 46mm +4mm offset: (b)(6).320-15-01 - eq rev glenoid plate: (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0: (b)(6).
Event or Problem Description
Approximately 1 year(s), 6 month(s) and 14 day(s) post-operative of a revised non-exactech left tsa, it was reported via clinical study that the patient experienced aseptic humeral loosening patient states they hit their arm on a door.The patient underwent a standard reverse revision of a competitor¿s devices.Prior to this event, the patient was implanted with an antibiotic spacer due to an unknown infection.The outcome of this event is considered resolved and the clinical report indicates that this event is possibly related to the device(s) and/or to the procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of an insufficient bond between the humeral stem and the bone, which led to aseptic (non-infected) humeral loosening.Potential contributions of manufacturing, user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, relevant clinical information, and product information was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 14MM
• 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20429272
• Report Number: 1038671-2024-03946
• Device Sequence Number: 7860744
• Product Code: HSD
• UDI-Device Identifier: 10885862283023
• UDI-Public: 10885862283023
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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 Catalogue Number: 300-01-14
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 04/30/2025
• Date Device Manufactured: 02/22/2021
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 147 KG
• Patient Race: White