MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/22/2022

Event Type  Injury  

Event Description

It was reported via a clinical study, ¿equinoxe shoulder study¿, that a 38 yo female patient, who had an initial total shoulder implanted on (b)(6) 2022, was fixed intraoperatively for a humeral calcar fx from a previous hardware removal intra-op.3 small 3.5mm headless screw compression screws were removed.Autograft bone graft was used behind the baseplate.The event was definitely not related to the device, but definitely related to the procedure.The clinical study indicates the event was resolved on (b)(6) 2022.No further information.

Manufacturer Narrative

D10: concomitants: 7075775 300-30-06 - equinoxe preserve stem 6mm; a157773 300-10-45 - equinoxe replicator plate 4.5mm o/s; a182574 314-23-02 - laser cage glenoid small, alpha.Additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: EQUINOXE
• Type of Device: 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 66 court; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18691182
• MDR Text Key: 335186067
• Report Number: 1038671-2024-00202
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA)
• Device Catalogue Number: 310-01-44
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2023
• Date Device Manufactured: 06/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American