MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	300-01-15
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Periprosthetic fracture (4902)
Date of Event	09/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 72 y/o male patient was revised due a periprosthetic fracture of the left humeral stem.Surgeon removed the patient's glenosphere, liner, tray and stem.He implanted a 42+4 glenosphere.Patient was last known to be in stable condition following the event.Devices will not be retuning.
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 320-01-42 - equinoxe reverse 42mm glenosphere 3812272, lot #: 61791005, 320-10-00 - equinoxe reverse tray adapter plate tray +0 3880888, 320-15-01 - eq rev glenoid plate 3835727, 320-15-05 - eq rev locking screw 3890473, 320-20-00 - eq reverse torque defining screw kit 3858197, 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm 3829788, 3854701, 320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm 3854758, 320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm 3865016, 320-42-03 - equinoxe reverse 42mm humeral liner +2.5 3868573.
Event or Problem Description
It was reported that this 72 y/o obese male patient was revised due a periprosthetic fracture of the left humeral stem.The surgeon removed the patient's glenosphere, liner, tray, and stem.The surgeon implanted a 42+4 glenosphere.There were no reported issues with the surgical revision procedure.The patient was last known to be in stable condition following the event.The devices will not be returned.No additional information after multiple attempts.
Additional Manufacturer Narrative
Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of surgical revision for periprosthetic fracture cannot be conclusively determined; however, it is most likely patient related conditions as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.Section h11: (b5) describe event or problem: it was reported that this 72 y/o obese male patient was revised due a periprosthetic fracture of the left humeral stem.The surgeon removed the patient's glenosphere, liner, tray, and stem.The surgeon implanted a 42+4 glenosphere.There were no reported issues with the surgical revision procedure.The patient was last known to be in stable condition following the event.The devices will not be returned.No additional information after multiple attempts.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b3 (remove erroneous date from initial report-unknown), d8, h4, h6 clinical code, medical device problem code and investigation findings code.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15742783
• Report Number: 1038671-2022-01415
• Device Sequence Number: 5660654
• Product Code: KWT
• UDI-Device Identifier: 10885862079336
• UDI-Public: 10885862079336
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2025

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: 01/18/2025
• Device Model Number: 300-01-15
• Device Catalogue Number: 300-01-15
• Device Lot Number: 06072108
• 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: 10/18/2022
• Supplement Date Received by Manufacturer: 11/23/2022; 11/11/2025
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 12/15/2022; 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2015
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 109 KG