MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 7MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 7MM
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Periprosthetic fracture (4902)
Date of Event	09/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, female patient had a periprosthetic fracture of the stem.Patient was revised to hrp.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-rays and photos received.The device is not available for evaluation due to hospital policy.
Additional Manufacturer Narrative
Section b5: additional information received indicates that patient's bone was broken on distal part of the stem.Section d10: concomitant products: equinoxe reverse 38mm glenosphere (cat#: 320-01-38 / serial#: (b)(6).Equinoxe reverse tray adapter plate tray +0 (cat#: 320-10-00 / serial#: (b)(6).Eq rev glenoid plate (cat#: 320-15-01 / serial#: (b)(6).Eq rev locking screw (cat#: 320-15-05 / serial#: (b)(6).Eq reverse torque defining screw kit (cat#: 320-20-00 / serial#: (b)(6).Eq rev compress screw lck cap kit, 4.5 x 22mm (cat#: 320-20-22 / serial#: (b)(6).Eq rev compress screw lck cap kit, 4.5 x 22mm (cat#: 320-20-22 / serial#: (b)(6).Eq rev compress screw lck cap kit, 4.5 x 26mm (cat#: 320-20-26 / serial#: (b)(6).Eq rev compress screw lck cap kit, 4.5 x 30mm (cat#: 320-20-30 / serial#: (b)(6).145-deg pe 38mm hum liner +0 (cat#: 320-38-00 / serial#: (b)(6).(h3) as reported, female patient had a periprosthetic fracture of the stem.Patient was revised to hrp.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-rays and photos received.The device is not available for evaluation due to hospital policy.Upon review of the available information, there is no evidence that this is a device related problem and there is no allegation against the device.Implantation of a total joint could result pain, infection, or loosening of total joint hardware.The most likely cause of the reported event was a malunion of a fracture which was likely caused by over-reaming during implantation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b5, d2a, d2b, d8, h6: clinical code, medical device problem code, component code, investigation conclusions.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
X-ray and photos received did not pertain to this patient.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 7MM
• 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15720381
• Report Number: 1038671-2022-01373
• Device Sequence Number: 2995765
• Product Code: KWS
• UDI-Device Identifier: 10885862079299
• UDI-Public: 10885862079299
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• 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): 11/06/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/14/2019
• Device Model Number: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 7MM
• Device Catalogue Number: 300-01-07
• 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: 10/13/2022
• Supplement Date Received by Manufacturer: 04/17/2023; 11/06/2025
• Initial Report FDA Received Date: 11/03/2022
• Supplement Report FDA Received Date: 05/09/2023; 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2009
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female