MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-38-03

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

Patient Problem Joint Laxity (4526)

Event Date 06/06/2023

Event Type  Injury  

Manufacturer Narrative

D10.Concomitants: (b)(6).320-15-01 - eq rev glenoid plate.(b)(6).300-01-11 - equinoxe, humeral stem primary, press fit 11mm.(b)(6).320-08-38 - glenosphere exp 38mm +4mm offset.(b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0.

Event Description

It was reported via clinical study, that approximately 3 years postop the initial implant, this 63 yo male patient was revised due to instability / subluxation.The patient¿s outcome was last known as resolved.The case report form indicates this event is unlikely related to device and unlikely related to procedure.Devices will not be returned.

• Brand Name: EQUINOXE
• 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 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17504735
• MDR Text Key: 320853890
• Report Number: 1038671-2023-01930
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086662
• UDI-Public: 10885862086662
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-38-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2020
• 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): Other; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Race: White