MAUDE Adverse Event Report: EXACTECH, INC. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 320-20-30

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 09/08/2022

Event Type  Injury  

Event Description

It was reported that this male patient's right shoulder was revised.Incident occurred when the patient went to wash his hair and he felt a pop and pain.On examination of an x-ray it showed that we had multiple fixation screws broken behind the glenoid plate.Surgeon removed our glenosphere and glenoid plate.Replacing it with an arthrex 6.5 center screw glenoid plate and a 42 arthrex glenosphere.He then placed a +5 adapter tray and a +0 humeral liner both exactech products.Surgeon removed our glenosphere and glenoid plate.Replacing it with an arthrex 6.5 center screw glenoid plate and a 42 arthrex glenosphere.He then placed a +5 adapter tray and a +0 humeral liner both exactech products.

Manufacturer Narrative

Pending evaluation.Concomitant medical device(s): 300-30-06 - equinoxe preserve stem 6mm, (b)(4), 320-06-42 - glenosphere 42mm, (b)(4), 320-10-00 - equinoxe reverse tray adapter plate tray +0, (b)(4), 320-15-05 - eq rev locking screw, (b)(4), 320-20-00 - eq reverse torque defining screw kit, (b)(4), 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, (b)(4), 320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm, (b)(4), 320-42-03 - equinoxe reverse 42mm humeral liner +2.5, (b)(4), 320-15-01 - eq rev glenoid plate, (b)(4).

Manufacturer Narrative

Section h10: (h3) the revision reported was likely the result of the glenoid baseplate not achieving long-term fixation, causing the compression screws to bear the joint load and eventually fracture.However, this cannot be confirmed as the devices were not returned for evaluation and adequate information was not provided to determine the root cause of the insufficient glenoid baseplate fixation.

• Brand Name: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM
• 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: kate jacobson ; 3523771140
• MDR Report Key: 15536720
• MDR Text Key: 301124693
• Report Number: 1038671-2022-01230
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086556
• UDI-Public: 10885862086556
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-20-30
• Device Catalogue Number: 320-20-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2021
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Sex: Male