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 Failure of Implant (1924)

Event Date 01/09/2024

Event Type  Injury  

Manufacturer Narrative

H3: pending investigation.D10: (b)(6) 315-35-00 - glnd kwire.(b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6) 320-20-00 - eq reverse torque defining screw kit 6446897 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(6) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(6) 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6) 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.(b)(6) 320-31-36 - glenosphere, 36mm.(b)(6) 321-20-00 - equinoxe reverse shoulder drill kit.

Event Description

As reported, the patient had a left rtsa on (b)(6) 2020.A different surgeon scheduled a revision of the shoulder for (b)(6) 2024.Based on the x-ray it looked like the glenosphere baseplate came loose from the glenoid, and one screw broke.The surgeon ended up putting in an antibiotic spacer and plans to revise it back to a reverse at another date.There was no reported surgical delay/prolongation.The patient was last known to be in stable condition following the event.Related to 1038671-2024-00170.

• 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, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: michael crader ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18806343
• MDR Text Key: 336515755
• Report Number: 1038671-2024-00343
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/29/2024

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: 320-15-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/11/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female