MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products: - humeral stem or stemless (cat# 300-01-13).- reverse humeral liner (cat# 320-38-00).- reverse humeral tray (cat# 320-10-00).- reverse glenosphere baseplate (cat# 320-15-06).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the equinoxe shoulder study, the 83 y/o female patient experience a difficult dislocation greater tuberosity fractured, remaining un-displaced.Patient came to 6 month check up and is happy with her shoulder replacement.Per clinical study report the reported event is not related to the device and possibly related to the procedure.
Additional Manufacturer Narrative
(d10) reported concomitant device(s): 320-38-00 - equinoxe reverse 38mm humeral liner +0.320-10-00 - equinoxe reverse tray adapter plate tray +0.320-01-38 - equinoxe reverse 38mm glenosphere.320-15-06 - rs glenoid plate ext cag +10mm cage peg.This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h6, h11.The following sections were corrected: d1, d2a, d2b, d4 - model number, catalog number, udi, d10, e1 - city, zip code, g1 - contact first, last name, g4 - 510k number.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation - remains implanted; further, photographs and/or radiograph images were not provided for review.A definitive root cause was unable to be determined; however, may have resulted a combination of forces applied during the surgical procedure or patient-related risk factors.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The cause of the bone fracture reported cannot be conclusively determined but may be related to a combination of forces applied during the surgical procedure or patient-related risk factors.However, this cannot be confirmed because relevant patient information, images, or radiographs were not 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 13MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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 ; 3523771140
• MDR Report Key: 17628951
• Report Number: 1038671-2023-02059
• Device Sequence Number: 12380421
• Product Code: KWS
• UDI-Device Identifier: 10885862079329
• UDI-Public: 10885862079329
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 01/06/2025

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 Model Number: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM
• 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: Not provided
• Supplement Date Received by Manufacturer: 11/19/2024; 01/06/2025
• Initial Report FDA Received Date: 08/27/2023
• Supplement Report FDA Received Date: 12/06/2024; 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 83 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Race: White