MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 42MM HUMERAL LINER +0

Model Number 320-42-00

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

Patient Problem Bacterial Infection (1735)

Event Date 09/10/2021

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 320-10-00, 6867691 - equinoxe reverse tray adapter plate tray +0.320-01-42, 6644314 - equinoxe reverse 42mm glenosphere.320-15-05, 6833029 - eq rev locking screw.320-20-00, 6895905 - eq reverse torque defining screw kit.300-01-15, 611330 - equinoxe, humeral stem primary, press fit 15mm.320-15-04, 6701688 - rs glenoid plate r post aug, 8 deg, right.

Event Description

As reported, approximately 3 mos postop the initial rtsa, this event was a one stage revision of exactech implants due to infection.After considerate removing of infected tissue and debridement, the humeral tray and liner were removed as well as the glenosphere and locking screw.The surgeon then washed the wound and implanted a new 42mm glenosphere, locking screw, +0mm humeral tray and 42 +0 humeral liner.Implanted a new 42mm glenosphere, locking screw, +0mm humeral tray and 42 +0 humeral liner.The patient was last known to be in stable condition following the event.Devices were disposed by hospital.

Manufacturer Narrative

(h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: EQUINOXE
• Type of Device: REVERSE 42MM HUMERAL LINER +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 12562436
• MDR Text Key: 274583876
• Report Number: 1038671-2021-00502
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• 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,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-42-00
• Device Catalogue Number: 320-42-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male