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

Model Number	314-13-23
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/09/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1038671-2021-00725
• Device Sequence Number: 11734413
• Product Code: KWT
• UDI-Device Identifier: 10885862196170
• UDI-Public: 10885862196170
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male