MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; CAGE GLENOID MEDIUM, ALPHA

Model Number 314-13-03

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 310-01-44, 6510130 - equinoxe, humeral head short, 44mm (alpha).300-10-45, 6599394 - equinoxe replicator plate 4.5mm o/s.300-20-02, 6643926 - equinox square torque define screw drive kit.300-01-11, 6698962 - equinoxe, humeral stem primary, press fit 11mm.531-78-20, 6719378 - shouldr gps hex pins kit.

Event Description

A female patient reported she had a tsa in (b)(6) of 2020, and alleges that in (b)(6) of 2021, the glenoid had ¿broken apart¿.No other information at this time.

Manufacturer Narrative

Section h10: (h3) the revision reported in 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 MEDIUM, ALPHA
• 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: 12726843
• MDR Text Key: 279258208
• Report Number: 1038671-2021-00558
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862172686
• UDI-Public: 10885862172686
• 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: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 314-13-03
• Device Catalogue Number: 314-13-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2020
• 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 Sex: Female