MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM; PROSTHESIS, SHOULDER, NON-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 Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	12/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 320-32-36 - expanded glenosphere, 36mm, for small reverse: 6176176 320-35-07 - small superior/posterior aug glenoid plate,left: 6169021 320-36-00 - 36mm humeral liner +0 unconstrained: 6207450 300-01-11 - equinoxe, humeral stem primary, press fit 11mm: 5686361 320-10-00 - equinoxe reverse tray adapter plate tray +0: 6251809 320-15-05 - eq rev locking screw: 6217492 320-20-00 - eq reverse torque defining screw kit: 6224279 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm: 5601146 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm: 6221857 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm: 6185927 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm: 6248382 531-20-00 - shldr gps rvrs drill kit: 6248648 531-78-20 - shouldr gps hex pins kit: 6260535 a10012 - gps implant kit v2: 10000219180 asa0030 - sterile disposable containers: ab5353 cnl-09 - small cement cannula: ab3449 13a2101 - cemex system fast genta 70g: ab4106.
Event or Problem Description
Post-operative of a left tsa, it was reported via clinical study that the patient experienced a humeral fracture.Avulsion of the greater tuberosity, and it is now displaced posteriorly and superiorly.The patient was given modified physical therapy protocol.The patient in no pain, fractured appears healed on x-ray and the outcome of this event is considered resolved.The clinical report indicates that this event is definitely related to the device(s) and/or to the procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, d4, g4, h4, h6.Mdr section codes updated/corrected: b, c, d, e, f, g.The reason for the post operative bone fracture reported 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.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 11MM
• 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20044751
• Report Number: 1038671-2024-03026
• Device Sequence Number: 12755303
• Product Code: KWT
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 08/13/2024
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2018
• 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.
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 74 KG