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

Model Number	EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by equinoxe shoulder study, approximately seventeen days post initial tsa, the 74 y/o female experienced humeral fracture.Event was resolved.Patient follow up at 1 year post op.Patient happy with outcome and realistic expectations.Per clinical report the reported event is possibly related to the device and the procedure.
Additional Manufacturer Narrative
Section d10: concomitant products: humeral stem or stemless (cat# 300-01-09); 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.
Additional Manufacturer Narrative
(d10) reported concomitant device(s): 320-38-00 - equinox reverse 38mm humeral liner +0.320-10-00 - equinox reverse tray adapter plate tray +0.320-01-38 - equinox 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; further, photographs and/or radiograph images were not provided for review.A definitive root cause was unable to be determined; however, may have resulted from patient condition, forces applied during the surgical procedure, or an unreported trauma in the post-operative period.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, 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: 17628952
• Report Number: 1038671-2023-02060
• Device Sequence Number: 20451423
• Product Code: KWS
• UDI-Device Identifier: 10885862079305
• UDI-Public: 10885862079305
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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 9MM
• 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: Not provided
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 08/27/2023
• Supplement Report FDA Received Date: 12/06/2024
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Race: White