MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM GLENOSPHERE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE REVERSE 38MM GLENOSPHERE

Device Problem Naturally Worn (2988)

Patient Problem Unspecified Infection (1930)

Event Date 12/22/2023

Event Type  Injury  

Manufacturer Narrative

Section d10: concomitant products: equinoxe reverse shoulder glenosphere locking screw (cat# 320-15-05 / serial# (b)(6).Equinoxe reverse shoulder fixed angle torque defining screw kit (cat# 302-20-00 / serial# (b)(6).Equinoxe reverse shoulder humeral adapter tray +0 (cat# 320-10-00 / serial# (b)(6).Equinoxe reverse shoulder humeral liner 38mm +2.5mm (cat# 320-38-03 / serial# (b)(6).Equinoxe, humeral stem primary, press fit 7mm (cat# 300-01-07 / serial# (b)(6).Rs glenoid plate post aug, 8 deg, left (cat# 320-15-03 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, approximately fourteen days post initial left tsa, the 65 y/o male patient reverse shoulder was revised due to infection.All components were revised due to an infection.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photos/x-rays.The devices are not available for evaluation due to hospital disposed the implants.

• Brand Name: EQUINOXE REVERSE 38MM GLENOSPHERE
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: miguel soza
• MDR Report Key: 18735595
• MDR Text Key: 335719406
• Report Number: 1038671-2024-00257
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K06356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE 38MM GLENOSPHERE
• Device Catalogue Number: 320-01-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2023
• 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: 65 YR
• Patient Sex: Male