MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number 320-38-00

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 05/01/2023

Event Type  Injury  

Manufacturer Narrative

Pending investigation.D10: (b)(6), 321-20-00 - equinoxe reverse shoulder drill kit.(b)(6), 320-20-00 - eq reverse torque defining screw kit.(b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6), 300-01-09 - equinoxe, humeral stem primary, press fit 9mm.(b)(6), 320-01-38 - equinoxe reverse 38mm glenosphere.(b)(6), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.(b)(6), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6), 320-15-01 - eq rev glenoid plate.(b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6), 320-15-05 - eq rev locking screw.

Event Description

As reported, the patient had an initial left tsa on (b)(6) 2015.The patient was revised on an unknown date.Part of the poly had worn away.The surgeon deemed it infected.He also, after trying to remove the glenosphere, realized that it was never put on properly.Primary implant was by another surgeon.An antibiotic spacer was implanted.There was no reported breakage of a device or surgical delay/prolongation.No other patient information/medical history reported.

• Brand Name: EQUINOXE REVERSE 38MM HUMERAL LINER +0
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17177538
• MDR Text Key: 317635566
• Report Number: 1038671-2023-01431
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10885862086655
• UDI-Public: 10885862086655
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2019
• Device Model Number: 320-38-00
• Device Catalogue Number: 320-38-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/30/2023
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/09/2014
• 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: 75 YR
• Patient Sex: Female