MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-01-09
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an 80 yo female patient, initial right shoulder implanted in (b)(6) 2023, underwent a revision procedure in (b)(6) 2024, approximately 1 year post the initial procedure.The patient presented with a fractured, ¿smashed¿, shoulder.The equinoxe reverse was taken out and a new reverse plus hrp were implanted.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.An x-ray was provided.The explanted devices are not available for analysis as they were discarded at the hospital.Device images were provided.No further information.
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 300-01-09 - equinoxe, humeral stem primary, press fit 9mm.(b)(6) 320-01-38 - equinoxe reverse 38mm glenosphere.(b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6) 320-10-05 - equinoxe reverse tray adapter plate tray +5.(b)(6) 320-10-10 - equinoxe reverse tray adapter plate tray +10.(b)(6) 320-15-01 - eq rev glenoid plate.(b)(6) 320-15-05 - eq rev locking screw.(b)(6) 320-20-00 - eq reverse torque defining screw kit.(b)(6) 320-20-00 - eq reverse torque defining screw kit.(b)(6) 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.(b)(6) 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.(b)(6) 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6) 320-38-13 - equinoxe reverse 38mm humeral const liner +2.5.(b)(6) 321-20-00 - equinoxe reverse shoulder drill kit.(b)(6) 321-52-09 - 3.2mm k-wire, trocar tip.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3 - according to the information provided, the female patient underwent a reverse shoulder replacement surgery on (b)(6) 2023.Approximately 1 year later, on (b)(6) 2024, the patient was revised due to humeral bone fracture.The patient is believed to have fallen.Bone quality was also likely a contributing factor.The devices were not returned for evaluation.Images and a radiograph were provided with the experience report.The reason for the revision reported was likely due to a periprosthetic humeral bone fracture related to the patient¿s poor bone quality and possible fall.The fracture was confirmed from the provided radiograph.H6 - component code, investigation type, findings, conclusion codes.
Event or Problem Description
The representative for the case, "believed the patient had fallen over - with brittle bone".
Additional Manufacturer Narrative
"this follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported was likely due to a periprosthetic humeral bone fracture related to the patient¿s poor bone quality and possible fall.The fracture was confirmed from the provided radiograph.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 9MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 20165029
• Report Number: 1038671-2024-03348
• Device Sequence Number: 7300888
• Product Code: KWT
• UDI-Device Identifier: 10885862079305
• UDI-Public: 10885862079305
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2025

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: 300-01-09
• 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: 09/06/2024
• Supplement Date Received by Manufacturer: 11/27/2024; 02/03/2025
• Initial Report FDA Received Date: 09/07/2024
• Supplement Report FDA Received Date: 12/13/2024; 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2023
• 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; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female