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

Catalog Number 300-01-14

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 12/01/2021

Event Type  Injury  

Event Description

It was reported via clinical study, that approximately 13 days postop the initial implant, this 43 yo male patient was revised due to a deep infection.The patient¿s outcome was last known as resolved.Devices will not be returned.

Manufacturer Narrative

Concomitant medical products: serial number; item number and full description.(b)(6) - glenosphere exp 42mm +4mm offset, (b)(6) - equinoxe reverse tray adapter plate tray +0, (b)(6) - eq rev glenoid plate, (b)(6) - 145-deg pe 42mm hum liner +2.5.

• 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: 17597797
• MDR Text Key: 321678416
• Report Number: 1038671-2023-02011
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10885862283023
• UDI-Public: 10885862283023
• 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: 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: 300-01-14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2019
• 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): Other; Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Race: White