MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-10-00

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

Patient Problem Failure of Implant (1924)

Event Date 03/08/2024

Event Type  Injury  

Event Description

As reported by the equinoxe shoulder study, the 78-year-old white female had a left tsa on (b)(6) 2012.The patient presented with aseptic glenoid loosening on (b)(6) 2024.Suspicion for glenoid component loosening and possible scapular spine fracture was reported with this event.A ct scan was ordered for the patient and the outcome of this event is considered continuing.The case report form indicates that this event is possibly related to the device and unlikely related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.

Manufacturer Narrative

H3: pending investigation.D10: 320-38-00 - 145-deg pe 38mm hum liner +0 : (b)(6).320-02-38 - rs expanded glenosphere 38mm, +4mm offset : 2239645 320-15-05 - eq rev locking screw : (b)(6).320-20-00 - eq reverse torque defining screw kit : (b)(6).H7: z-1418-2024.

• Brand Name: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: matt collins ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19152895
• MDR Text Key: 340715441
• Report Number: 1038671-2024-00918
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086419
• UDI-Public: 10885862086419
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2022
• Device Catalogue Number: 320-10-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/09/2012
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Race: White