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

Model Number EQUINOXE REVERSE 42MM GLENOSPHERE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 09/30/2022

Event Type  Injury  

Manufacturer Narrative

Concomitants: (b)(4) 300-01-11 - equinoxe, humeral stem primary, press fit 11mm.(b)(4) 315-35-00 - glnd kwire.(b)(4) 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(4) 320-15-01 - eq rev glenoid plate.(b)(4) 320-15-05 - eq rev locking screw.(b)(4) 320-20-00 - eq reverse torque defining screw kit.(b)(4) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(4) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(4) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(4) 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.(b)(4) 320-42-00 - equinoxe reverse 42mm humeral liner +0.(b)(4) 531-78-20 - shouldr gps hex pins kit.

Event Description

It was reported that a 67 yo male patient, had an initial left shoulder implanted on (b)(6) 2022, then underwent a 2-stage revision, approximately 5 months post the initial procedure.The reverse total shoulder was removed for infection as a part of a 2-stage revision.The patient was not revised to exactech devices.There were no reported issues during the surgical revision procedure.The patient was last known to be in stable condition following the event.The products are not returning; implants required for collection of infected materials ¿ sent to hospital pathology.No additional information.

• Brand Name: EQUINOXE
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15674606
• MDR Text Key: 302436173
• Report Number: 1038671-2022-01351
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086396
• UDI-Public: 10885862086396
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Type of Report: Initial
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE 42MM GLENOSPHERE
• Device Catalogue Number: 320-01-42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2022
• Date Device Manufactured: 08/13/2021
• 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 Sex: Male