MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	300-01-13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 1 year 5 months after a left total shoulder replacement, the patient suffered a periprosthetic humeral fracture and needed plating and stem replacement.The patient was not revised to exactech devices.The event was not related to the breakage of the device.The event did not lead to a surgical delay/prolongation.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending investigation.D10: a249934, 320-01-38 - equinoxe reverse 38mm glenosphere.A299972, 320-10-00 - equinoxe reverse tray adapter plate tray +0.A066431, 320-15-02 - rs glenoid plate sup aug, 10 deg.A281406, 320-15-05 - eq rev locking screw.A255560, 320-20-00 - eq reverse torque defining screw kit.A209798, 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.A257076, 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.S393422, 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.A177144, 320-38-00 - equinoxe reverse 38mm humeral liner +0.A242276, 531-20-00 - shldr gps rvrs drill kit.A233072, 531-78-20 - shouldr gps hex pins kit.06000522027, a10012 - gps implant kit v2.
Additional Manufacturer Narrative
Result of investigation: the reason for the revision was likely due to a periprosthetic bone fracture.The cause of the bone fracture cannot be conclusively determined but may be related to a patient condition.However, this cannot be confirmed because the devices were not returned for evaluation, and relevant patient information, images, or radiographs were not provided.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM
• 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, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19728971
• Report Number: 1038671-2024-02374
• Device Sequence Number: 8148331
• Product Code: HSD
• UDI-Device Identifier: 10885862079329
• UDI-Public: 10885862079329
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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 Catalogue Number: 300-01-13
• 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: 06/27/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female