MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-38-00

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

Patient Problem Bacterial Infection (1735)

Event Date 06/03/2021

Event Type  Injury  

Manufacturer Narrative

Section h10: (h3) pending evaluation (d10) concomitant device(s): 6389934 - 320-10-05 - equinoxe reverse tray adapter plate tray +5.6535125 - 320-15-07 - sup/post aug plate, l rs glenoid baseplate.6539212 - 321-52-07 - 3.2mm drill bit sterile.6539724 - 320-15-06 - rs glenoid plate ext cag +10mm cage peg.6544562 - 321-52-09 - 3.2mm k-wire, trocar tip.6614881 - 300-01-10 - equinoxe humeral stem primary press fit 10mm.6687160 = 320-06-38 - glenosphere 38mm.6748235 - 315-35-00 - glnd kwire.6761488 - 315-35-00 - glnd kwire.6804424 - 320-15-05 - eq rev locking screw.6807822 - 320-20-00 - eq reverse torque defining screw kit.S120682 - 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.S123681 - 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.S200725 - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.S206822 - 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.S212330 - 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.S222254 - 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.

Event Description

It was reported via a voluntary medwatch report #mw5152512 , that a male patient, initial left shoulder implanted on (b)(6), 2021, underwent a revision procedure on (b)(6) 2021, approximately 3 months post the initial procedure.The reporter called to report problems after her husband received 2 equinoxe shoulder system replacements, each for the left shoulder.The reporter states her husband had initial shoulder replacement surgery on (b)(6) 2021, and came down with an infection almost immediately after implant.The reporter stated her husband continually communicated to the surgeon he was having pain in his shoulder and that it wasn¿t feeling right, however the surgeon dismissed that anything was wrong.The reporter stated that this process continued for 2 months before the surgeon¿s office believed that there was an infection.The reporter states that on an unknown date in 2021, as she was rubbing pain-relieving cream on her husband¿s shoulder, she noticed a ¿bright red, puffy, swollen lump, about 3 inch by 3 inch in size¿ on her husband¿s shoulder.She states a ct scan was performed on an unknown date in 2021, which showed infection.The reporter states a ¿50cc syringe¿ of pus was drained from this lump, and when the physicians assistant applied slight pressure, pus and fluid squirted out on her uniform.She states surgery was performed on (b)(6), 2021, and all shoulder components were removed except for the shoulder ball, and the shoulder site was thoroughly washed out before a new equinoxe device was again implanted.She states her husband was prescribed doxycycline at that time and continues with that prescription today.The reporter states that after this replacement surgery, her husband continued to experience pain and limited range of motion in the left shoulder.No further information.

• Brand Name: EQUINOXE REVERSE 38MM HUMERAL LINER +0
• 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; 2320 nw 66th court; gainesville 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19122304
• MDR Text Key: 340340072
• Report Number: 1038671-2024-00875
• Device Sequence Number: 1
• Product Code: KWT
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-38-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/27/2020
• 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 Sex: Male