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

Catalog Number 320-06-38

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

Patient Problem Bacterial Infection (1735)

Event Date 12/01/2023

Event Type  Injury  

Manufacturer Narrative

Section h10: (h3) pending evaluation.(d10) concomitant device(s): (b)(6).304-22-13 - 12.5mm platform fx stem right.(b)(6).315-35-00 - glnd kwire.(b)(6).320-06-38 - glenosphere 38mm.(b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6).320-15-01 - eq rev glenoid plate.(b)(6).320-15-05 - eq rev locking screw.(b)(6).320-20-00 - eq reverse torque defining screw kit.(b)(6).320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6).320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6).320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6).320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6).320-38-00 - 145-deg pe 38mm hum liner +0.(b)(6).321-20-00 - equinoxe reverse shoulder drill kit.

Event Description

As reported, approximately 2.5 months post op initial right tsa, this 87 y/o male patient was revised due to infection.No known event occurred.The patient developed a seroma.The patient developed a seroma, per the surgeon.The patient was opened for i&d.The surgeon removed the humeral liner, glenosphere screw, & glenosphere.The tissue around the joint showed signs of infection.The implants were found to be stable.The inside of the glenosphere was observed to have biologic build-up.Care was taken to clean the joint prior to implanting new components.Patient was last known to be in stable condition following the event.Product not returning - facility policy.

• Brand Name: GLENOSPHERE 38MM
• 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 ct; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18360600
• MDR Text Key: 330933287
• Report Number: 1038671-2023-03035
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• 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: 12/19/2023

1 Device was Involved in the Event

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: 320-06-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2023
• Initial Date FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2023
• 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 Age: 87 YR
• Patient Sex: Male