MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; CAGED GLENOID

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

Patient Problem Failure of Implant (1924)

Event Date 03/18/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant device(s): humeral head, replicator plate.

Event Description

As reported, post op the initial right tsa, this (b)(6) male patient's was revised due loosening.Surgeon revised an anatomic total shoulder to a hemi.He removed the caged glenoid, humeral head, and replicator plate then replaced them.Center cage of the glenoid did not come out with the glenoid.The removal tool could not thread into the cage because it had broken.Osteotomes were used to remove the cage and half of the cage had broken.Sales representative clarified that there was no issue with the removal tool.There was a 5-15 min delay/prolongation but no adverse events as a result.Surgeon was happy with the outcome upon looking at final xray.Xray of pre op image is provided.Patient was last known to be in stable condition following the event.Devices will not be returning, doctor did not release.

Manufacturer Narrative

Section h10: (h3) the revision reported was likely the result of incomplete seating of the glenoid component during implantation due to either off-axis drilling of the peripheral holes relative to the center cage hole or inadequate drilling of the center cage hole during glenoid bone preparation, which allowed for the center cage to eventually wear through the polyethylene body leading to metal-on-metal contact between the center cage and the humeral head.Because the component was not returned to exactech for evaluation and limited information is available, the order of events and most likely underlying cause cannot be confirmed at this time.

• Brand Name: EQUINOXE
• Type of Device: CAGED GLENOID
• 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: 14043109
• MDR Text Key: 288793331
• Report Number: 1038671-2022-00384
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male