MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	300-01-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant devices: 300-01-15 - eq humeral stem primary, press fit 15mm: (b)(6); 320-42-00 - eq reverse 42mm humeral liner +0: (b)(6); 320-01-42 - eq reverse 42mm glenosphere: (b)(6); 320-10-00 - eq reverse tray adapter plate tray +0: (b)(6); 320-15-08 - sup/post aug, r rs glenoid baseplate: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
Approximately 10 year(s) post-operative of a right rtsa, it was reported via clinical study that the patient experienced a humeral fracture ¿ tuberosity.Patient has spontaneous onset of humeral stress fracture at the base of tuberosity.No actions were taken as a result of this event and the outcome is considered continuing.The case report form indicates that this event is unlikely related to the device(s) and definitely not related to the procedure.This was reported through clinical trial study data collection activities, no device return is anticipated, and no other information is available at this time.
Additional Manufacturer Narrative
The reason for the post operative bone fracture reported cannot be conclusively determined but may be related to implant positioning, patient bone quality, a trauma, and/or another patient related condition.However, this cannot be confirmed based on the information provided.D1: corrected d2: corrected d3: corrected d4: corrected d10: concomitant device(s): 320-42-00 - eq reverse 42mm humeral liner +0: (b)(6) 320-01-42 - eq reverse 42mm glenosphere: (b)(6) 320-10-00 - eq reverse tray adapter plate tray +(b)(6).320-15-08 - sup/post aug, r rs glenoid baseplate: 3813155 g4: corrected h6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM
• 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
• MDR Report Key: 21561397
• Report Number: 1038671-2025-01513
• Device Sequence Number: 9127497
• Product Code: HSD
• UDI-Device Identifier: 10885862079336
• UDI-Public: 10885862079336
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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 Expiration Date: 04/13/2024
• Device Catalogue Number: 300-01-15
• 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: 02/17/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 07/29/2025
• Date Device Manufactured: 04/15/2014
• 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: Other
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: White