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

Catalog Number 320-15-05

Device Problem Misassembly by Users (3133)

Patient Problem Failure of Implant (1924)

Event Date 11/29/2023

Event Type  Injury  

Manufacturer Narrative

H3: pending investigation.

Event Description

As reported, the patient had a prior revision on an unknown date.A second revision was performed on this patient on (b)(6) 2023 due to the glenosphere not being properly seated on the baseplate.This was seen on x-ray before the revision took place.During the revision it was obvious that the reason the glenosphere was not seated on the baseplate was because the glenosphere locking screw was not screwed into the baseplate at the time of the revision.The patient was revised to a new glenosphere, locking screw, humeral liner, humeral tray, and torque defining screw kit.There was no reported breakage of a device or surgical delay/prolongation.

• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18334316
• MDR Text Key: 330594284
• Report Number: 1038671-2023-02991
• 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: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• 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: 11/29/2023
• 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