MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products.Equinoxe reverse 42mm glenosphere (cat# 320-01-42 / serial# (b)(6).Equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / serial# (b)(6).Eq rev locking screw.(cat# 20-15-05 / serial# (b)(6).Eq reverse torque defining screw kit.(cat# 320-20-00 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately three months initial right tsa, the 80 y/o male patient had a revision as to the humeral stem had become loose due to a humerus fracture.The surgeon exchanged stem, glenosphere, humeral tray and liner.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sale rep was unable to obtain x-rays or images.The devices are not available for evaluation as they were discarded by the hospital.
Additional Manufacturer Narrative
Additional information: h3: the cause of the humeral loosening reported in this case appears to be due to fracture of the humerus.The cause of the bone fracture cannot be conclusively determined.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.H6 - problem code, component code, investigation codes.Corrected information: h6: medical device problem code.
Additional Manufacturer Narrative
Correction: h6 component code, h6 investigation conclusions.

• 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3525541928
• MDR Report Key: 18123238
• Report Number: 1038671-2023-02760
• Device Sequence Number: 7016021
• Product Code: KWT
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• 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: 10/20/2023
• Supplement Date Received by Manufacturer: 08/19/2024; 11/04/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 08/22/2024; 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male