MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID EXTRA LARGE, BETA; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 314-13-15

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 11/23/2022

Event Type  Injury  

Event Description

As reported, this 74 year old male patient had an initial right tsa on (b)(6) 2015.The patient presented with a painful shoulder with loose caged anatomic glenoid.The glenoid cage disassociated from the body of the glenoid and was removed.The glenoid was revised to a spacer.The patient currently has spacer in-situ awaiting custom glenoid.The event did not lead to a surgical delay/prolongation.The patient was last known to be in stable condition following the event.

Manufacturer Narrative

Pending investigation.Concomitant medical products: 3834850 300-01-15 humeral stem, 15mm.3926830 300-20-02 square torque defining screw kit.3627313 300-10-15 humeral head s 53mm.

Manufacturer Narrative

H3: the revision reported was likely the result of an insufficient bond between the glenoid component and the patient¿s glenoid bone, which allowed for the component to loosen and become painful.The cause of the center cage disassociation cannot be determined from the information provided but may have occurred due to incomplete drilling or seating of the pegs/cage during implantation, malalignment of the cage relative to the peripheral pegs during implantation, or while removing the component during the revision surgery.

• Brand Name: EQUINOXE CAGE GLENOID EXTRA LARGE, BETA
• Type of Device: PROSTHESIS, SHOULDER, SEMI-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: 15971729
• MDR Text Key: 305416648
• Report Number: 1038671-2022-01596
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10885862172723
• UDI-Public: 10885862172723
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2019
• Device Model Number: 314-13-15
• Device Catalogue Number: 314-13-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/30/2022
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2014
• 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 Age: 74 YR
• Patient Sex: Male