MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	300-01-09
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	11/11/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 1 year(s), 8 month(s) and 24 day(s) post-operative of a left rtsa, it was reported via clinical study that the patient experienced humeral fracture and unexplained pain.Patient seen in consultation from ed for worsening left shoulder pain of 3 days duration.X-rays in ed revealed worsening loss of reduction of humerus fracture.Patient reports worsening pain while at work with related popping noises.The patient previously underwent cerclage fixation for a periprosthetic humerus fracture.Unfortunately, the hardware has failed.In earlier events, the patient experienced two other humeral fractures that were resolved through open reductions.The patient underwent open reduction and internal fixation with screws, plate and cerclage wires, midshaft humerus, with iliac crest aspirate graft with optecure due to failed hardware.No implants were replaced.The outcome of this event is now considered resolved and the clinical report indicates that this event is possibly related to the device(s) and definitely related to the procedure.This was reported through clinical trial study data collection activities and no other information is available at this time.
Additional Manufacturer Narrative
(d10) concomitant device(s): 320-42-00 - equinoxe reverse 42mm humeral liner +0: (b)(6); 320-10-05 - equinoxe reverse tray adapter plate tray +5: (b)(6); 320-01-42 - equinoxe reverse 42mm glenosphere: (b)(6); 320-15-01 - eq rev glenoid plate: (b)(6).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d4, d8, h6.Mdr section codes updated/corrected: a, b, c, d.The reason for the post operative bone fracture reported in 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.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM
• 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: 20621046
• Report Number: 1038671-2024-04264
• Device Sequence Number: 18361330
• Product Code: HSD
• UDI-Device Identifier: 10885862079305
• UDI-Public: 10885862079305
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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 Expiration Date: 02/01/2023
• Device Catalogue Number: 300-01-09
• 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: 10/29/2024
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2013
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Race: White