MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-01-11
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	01/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 320-36-03 - 145-deg pe 36mm hum liner +2.5: (b)(6) ; 320-10-00 - equinoxe reverse tray adapter plate tray +0: (b)(6) ; 320-31-36 - glenosphere, 36mm: (b)(6) ; 320-35-03 - small posterior augment glenoid plate, left: (b)(6) ; 315-35-00 - glnd kwire: (b)(6) ; 319-01-32 - steinmann pin sterile 3.2mm x 178mm: (b)(6) ; 320-15-05 - eq rev locking screw: (b)(6) ; 320-20-00 - eq reverse torque defining screw kit: (b)(6); 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm: (b)(6); 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm: (b)(6); 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: (b)(6); 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm: (b)(6); 521-78-32 - threaded pin size 3.0 collarless 2pk: (b)(6); 531-78-20 - shouldr gps hex pins kit: (b)(6).(h3) pending evaluation.
Event or Problem Description
As reported by the equinoxe shoulder study, the 64-year-old male patient had a left tsa on (b)(6) 2024.The patient presented with a humeral fracture, intra-operatively on (b)(6)2024.Greater tuberosity fracture during the case.Bone was extremely osteoporotic.Had to use standard and cemented stem and convert to rtsa due to osteoporosis.The outcome of this event is considered continuing and the action taken was other - cerclage sutures around tuberosity at surgery.The case report form indicates that this event is definitely not related to the device and unlikely related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
The reason for the intraoperative bone fracture reported cannot be conclusively determined but may be related to a patient condition or high forces during broaching, reaming, exposure, or retraction.The patient had severe osteoporosis.However, this cannot be confirmed based on the information provided.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 18950558
• Report Number: 1038671-2024-00620
• Device Sequence Number: 20602528
• Product Code: KWS
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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: 300-01-11
• 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: 02/23/2024
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• 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 H10
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White