MAUDE Adverse Event Report: EXACTECH, INC. EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number 300-20-02

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 01/11/2024

Event Type  Injury  

Event Description

As reported by the equinoxe shoulder study, the 48 year old female patient had an initial left tsa on (b)(6) 2013 and presented with breakage - component, 10 year(s) and 6 month(s) post initial procedure on (b)(6) 2024.Broken screws at the glenoid baseplate interface.The case report form indicates that this event is definitiely related to the device and/or to the procedure.The report also indicates that the action taken was revision on (b)(6)2024 with the removal of the following components: standard humeral stem, replicator plate, torque screw, humeral head, glenoid.The outcome is reported as resolved.No device return anticipated due to being a clinical trial study.

Manufacturer Narrative

(h3) pending evaluation: (d10) concomitant device(s): (b)(6), 300-01-09 - equinoxe, humeral stem primary, press fit 9mm; (b)(6), 300-10-45 - equinoxe replicator plate 4.5mm o/s; (b)(6), 310-01-44 - equinoxe, humeral head short, 44mm (alpha); (b)(6), 314-13-02 - equinoxe cage glenoid small, alpha.

• Brand Name: EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT
• 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; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18724351
• MDR Text Key: 335708149
• Report Number: 1038671-2024-00247
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2018
• Device Catalogue Number: 300-20-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2013
• 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 Age: 48 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Race: Black Or African American