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

Model Number EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2023

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: serial number item number and full description, (b)(6).314-13-03 - equinoxe cage glenoid medium, alpha, (b)(6).300-10-15 - equinoxe replicator plate 1.5mm o/s, (b)(6).310-01-44 - equinoxe, humeral head short, 44mm (alpha).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported via a equinoxe shoulder study, that a 63 yo female patient, initial right shoulder implanted on (b)(6) 2019, underwent a revision procedure on (b)(6) 2023, approximately 3 years 11 months post the initial procedure due to aseptic humeral loosening.Date of onset,(b)(6) 2023.The standard humeral stem, replicator plate, torque screw, humeral head, and glenoid were removed.The subscapularis was repaired, and a biceps tenodesis was performed.The study states the event was definitely related to the devices and the procedure.The outcome indicates continuing.No device returns anticipated due to clinical study guidelines.No further information.

• 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: kate jacobson ; 3523771140
• MDR Report Key: 17643681
• MDR Text Key: 322198566
• Report Number: 1038671-2023-02083
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10885862079329
• UDI-Public: 10885862079329
• 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: 08/29/2023

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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 08/29/2023
• Date Device Manufactured: 04/10/2019
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Race: White