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 Codes	Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994)
Date of Event	12/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 2 weeks post the initial left reverse total shoulder arthroplasty, the patient was complaining of pain.On x-ray there was a calcar fracture, but was stable after opening up.The infection markers were up so a poly exchange and a washout was done with samples taken.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.D10: a10012 - gps implant kit v2 03024224052 320-02-38 - rs expanded glenosphere 38mm, +4mm offset (b)(6), 321-52-10 - 3.2mm k-wire, thd, short 2 k-wires per pack (b)(6), 320-15-03 - rs glenoid plate post (b)(6), deg, left (b)(6), 531-55-88 - ergo gps 3.2mm drill kit sterile (b)(6), 320-15-05 - eq rev locking screw (b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0 (b)(6), 320-20-00 - eq reverse torque defining screw kit (b)(6), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm (b)(6), 531-78-20 - shouldr gps hex pins kit (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), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm (b)(6).
Additional Manufacturer Narrative
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 review of the sterile certificates and/or the final endotoxin test reports was performed.All lots were accepted to the requirements.The reason for the reported revision due to suspected infection and bone fracture cannot be conclusively determined; however, it may be related to an underlying patient condition and/or the surgical procedure.Correction: h6 component code.

• 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: 21457886
• Report Number: 1038671-2025-01188
• Device Sequence Number: 7641693
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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: 300-01-13
• 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: 12/06/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2024
• 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: Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male