MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 12MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-01-12
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	12/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical study that intra-operatively the 77 yo female patient had a greater tuberosity fracture during surgery.Severely osteoporotic bone.Scarring of tuberosity from prior mini-open surgery.The action taken was orif with sutures around stem.The patient¿s outcome was last known as resolved on (b)(6) 2022.
Additional Manufacturer Narrative
Concomitant medical products:¿ serial #: (b)(4), category#: 315-35-00 glnd kwire, serial #: (b)(4), category#: 531-55-88 ergo gps 3.2mm drill kit sterile, serial #: (b)(4), category#: 320-35-08 small superior/posterior augglenoid plate,right, serial #: (b)(4), category#: 320-20-00 eq reverse torque defining screw kit, serial #: (b)(4), category#: 531-78-20 shouldr gps hex pins kit, serial #: (b)(4), category#: 320-31-36 glenosphere, 36mm, serial #: (b)(4), category#: 320-15-05 eq rev locking screw, serial #: (b)(4), category#: 320-10-00 equinoxe reverse tray adapter plate tray +0, serial #: (b)(4), category#: 320-36-00 145-deg pe 36mm hum liner +0, serial #: (b)(4), category#: 320-20-30 eq rev compress screw lck cap kit, 4.5 x 30mm, serial #: (b)(4), category#: 320-20-26 eq rev compress screw lck cap kit, 4.5 x 26mm, serial #: (b)(4), category#: 320-20-26 eq rev compress screw lck cap kit, 4.5 x 26mm, serial #: (b)(4), category#: 320-20-30 eq rev compress screw lck cap kit, 4.5 x 30mm, additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
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 bone fracture cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The reason for the intraoperative bone fracture reported cannot be conclusively determined but may be related to a patient condition.However, this cannot be confirmed based on the information provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 12MM
• 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 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16493065
• Report Number: 1038671-2023-00380
• Device Sequence Number: 20428638
• Product Code: KWT
• UDI-Device Identifier: 10885862283016
• UDI-Public: 10885862283016
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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 Catalogue Number: 300-01-12
• 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: 02/08/2023
• Supplement Date Received by Manufacturer: 09/28/2023; 07/28/2025
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 09/28/2023; 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• 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; Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White