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

Model Number 320-15-01

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 03/27/2023

Event Type  Injury  

Manufacturer Narrative

Pending investigation.D10: 300-30-06 equinoxe preserve stem 6mm, 320-06-38 glenosphere 38mm, 320-10-00 equinoxe reverse tray adapter plate tray +0, 320-15-05 eq reverse torque defining screw kit, 320-20-22 eq rev 38mm hum liner +2.5, 321-52-07 3.2mm drill bit sterile.

Event Description

As reported, the patient had an initial left rtsa on an unknown date.The patient was revised on (b)(6) 2023.The baseplate was retained.The glenosphere was replaced with a matching implant.The stem was removed and replaced with a competitors.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.

• Brand Name: EQ REV GLENOID PLATE
• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16766272
• MDR Text Key: 313558728
• Report Number: 1038671-2023-00742
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086488
• UDI-Public: 10885862086488
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-15-01
• Device Catalogue Number: 320-15-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/29/2023
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Required Intervention