MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-10-05

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

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 01/31/2024

Event Type  Injury  

Manufacturer Narrative

H3: pending investigation.D10: 5442391 320-02-42 - rs expanded glenosphere 42mm, +4mm offset.6730018 320-42-13 - equinoxe reverse 42mm humeral const liner +2.5.7292345 315-35-00 - glnd kwire a000416 300-01-13 - equinoxe, humeral stem primary, press fit 13mm.A051984 320-20-00 - eq reverse torque defining screw kit a085077 320-15-05 - eq rev locking screw.

Event Description

As reported, the patient had a previous right side revision on (b)(6) 2022.The patient was revised again on (b)(6) 2024 due to infection.All components were removed.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.

Manufacturer Narrative

H2: the cause of the patient¿s infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.General surgical risks include superficial or deep infection and delayed wound healing.It is a known complication that a patient¿s age, weight, activity level, and/or trauma would cause the surgeon to expect early failure of the system.These devices are used for treatment not diagnosis.

• Brand Name: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5
• 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 32653
• Manufacturer Contact: michael crader ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18757238
• MDR Text Key: 335990086
• Report Number: 1038671-2024-00286
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K110708
• 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: 07/08/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-10-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 06/11/2024
• Supplement Dates FDA Received: 07/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2018
• 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 Age: 80 YR
• Patient Sex: Male