MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; CAGE GLENOID L, POST AUG, RIGHT

Catalog Number 314-13-34

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 12/14/2021

Event Type  Injury  

Manufacturer Narrative

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.No information provided.

Event Description

As reported, approximately 2 years post op the initial rtsa, a (b)(6) male patient's poly disassociated from the pegs.Patient believes he felt a pop while lifting something.Patient was converted from a stemless tsa to a rtsa.There was no surgical delay or prolongation.Patient was last known to be in stable condition following the event.

• Brand Name: EQUINOXE
• Type of Device: CAGE GLENOID L, POST AUG, RIGHT
• 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: 13111745
• MDR Text Key: 284833180
• Report Number: 1038671-2021-00738
• Device Sequence Number: 1
• Product Code: KWT
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 314-13-34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/18/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male