MAUDE Adverse Event Report: EXACTECH, INC. EQ REV LOCKING SCREW; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-15-05

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2024

Event Type  Injury  

Event Description

It was reported via a voluntary medwatch report #mw5152512 , that a male patient, initial left shoulder implanted on (b)(6) 2021, who underwent a revision procedure on (b)(6) 2021, underwent a second revision procedure on (b)(6) 2024, approximately 2 years 7 months post the first revision procedure.Following the initial implant 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, confirmed by a ct scan.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 on (b)(6) 2021.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.She stated that on an unknown date in 2024, x-rays showed broken screws in the equinoxe shoulder system and an explant procedure was once again performed.They stated that on an unknown date in 2024, the surgical incision site developed a hematoma and required medical attention.She stated that in january 2024, she received a notification on her cell phone that the equinoxe shoulder system was ¿under a fda recall¿ and learned her husband¿s two equinoxe shoulder sytems were part of the recall.No further information.

Manufacturer Narrative

(h3) pending evaluation (d10) concomitant device(s): 3777348 - 320-10-15 - humeral tray +15mm 6580730 - 320-08-38 - glenosphere exp 38mm +4mm offset 6822073 - 300-01-11 - equinoxe, humeral stem primary, press fit 11mm 6943150 - 320-20-00 - eq reverse torque defining screw kit (b)6)- 320-15-05 - eq rev locking screw s244095 - 320-38-00 - 145-deg pe 38mm hum liner +0.

• Brand Name: EQ REV LOCKING SCREW
• 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 32653 ; 3523771140
• MDR Report Key: 19122324
• MDR Text Key: 340341099
• Report Number: 1038671-2024-00876
• 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: 320-15-05
• 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: 04/19/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male