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

Catalog Number 300-30-07

Device Problem Defective Device (2588)

Patient Problem Subluxation (4525)

Event Date 09/14/2020

Event Type  Injury  

Manufacturer Narrative

D10.Concomitants: serial number; item number and full description.(b)(6), 300-10-45 - equinoxe replicator plate 4.5mm o/s.(b)(6), 300-10-45 - equinoxe replicator plate 4.5mm o/s.(b)(6), 310-01-47 - equinoxe, humeral head short, 47mm (beta).(b)(6), 310-01-47 - equinoxe, humeral head short, 47mm (beta).(b)(6), 314-13-13 - equinoxe cage glenoid medium, beta.

Event Description

It was reported via clinical study, that approximately 2 months postop the initial implant, this 64 yo male patient was revised due to instability/subluxation.The patient¿s outcome was last known as resolved.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: 17599672
• MDR Text Key: 321712175
• Report Number: 1038671-2023-02019
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862515759
• UDI-Public: 10885862515759
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162726
• 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: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 300-30-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Race: White