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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant devices: 320-42-00 - eq rev 42mm humeral liner +0: (b)(6) 320-10-00 - eq rev tray adapter plate tray +0: (b)(6) 320-02-42 - rs exp glenosphere 42mm, +4mm offset: (b)(6) 320-15-04 - rs glenoid plate r post aug, 8 deg, right: (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 1 month(s) post-operative of a right rtsa, it was reported via clinical study that the patient experienced a (other) scapular fracture.Patient¿s arm was jerked while pumping gas.The patient underwent a standard reverse revision with the reported removal of the standard humeral stem component.The outcome of this event is now considered resolved and the case report form indicates that this event is possibly related to the device and possibly 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 revision reported was likely due to a bone fracture.The reason for the fracture 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.H6: corrected 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
• MDR Report Key: 21236443
• Report Number: 1038671-2025-00415
• Device Sequence Number: 12781328
• Product Code: KWS
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• 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: 2020
• Device Explanted Year: 2020
• 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: 01/07/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 01/25/2025
• Supplement Report FDA Received Date: 08/11/2025
• Date Device Manufactured: 01/31/2020
• 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: Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Race: White