MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; CAGE GLENOID M, POST AUG, LEFT

Model Number 314-13-23

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 12/09/2021

Event Type  Injury  

Event Description

As reported, almost 2 years post op left tsa, this male patient experienced discomfort for less than a 1 year after surgery.Surgeon removed the caged glenoid, poly had sheered off.Center cage was well fixed in glenoid but poly + 3 peripheral pegs were loose.Patient was last known to be in stable condition following the event.

Manufacturer Narrative

Section h10: h3: the revision reported was likely the result of failure of the cage glenoid component.Possible contributing factors include but are not limited to incomplete or off-axis seating of the glenoid component at the time of implantation, patient conditions, and/or abnormal forces being applied to the glenoid component during physical therapy, other physical activity, or a post traumatic event.The root cause of the failure cannot be determined because the device was not returned for evaluation and not enough information has been provided at this time.

• Brand Name: EQUINOXE
• Type of Device: CAGE GLENOID M, POST AUG, LEFT
• 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: 13060454
• MDR Text Key: 282629379
• Report Number: 1038671-2021-00725
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862196170
• UDI-Public: 10885862196170
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113309
• 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: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2024
• Device Model Number: 314-13-23
• Device Catalogue Number: 314-13-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 12/23/2021
• Supplement Dates FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2019
• 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; Hospitalization
• Patient Sex: Male