MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; GLENOSPHERE, 36MM

Model Number 320-31-36

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/23/2021

Event Type  Injury  

Event Description

As reported, approximately 10 months postop the primary l tsa, this (b)(6) female presented with a sudden onset of pain without an inciting event.Clinical scapular spine fracture was not visualized on x-ray.The patient has a pre-op history of avascular necrosis of humeral head.The reported action taken was to wear a sling and relative rest.Outcome reported as resolved on (b)(6) 2021.The case report form indicates this event is definitely related to devices and procedure.This event report was received through clinical data collection activities.Devices will not return due to study policy.

Manufacturer Narrative

Device evaluated by manufacturer? pending evaluation.Concomitant medical device(s): 300-30-06 - equinoxe preserve stem 6mm; 320-36-00 - 36mm humeral liner +0 unconstrained; 320-10-00 - equinoxe reverse tray adapter plate tray +0; 320-35-01 - small glenoid plate.

Manufacturer Narrative

(h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: EQUINOXE
• Type of Device: GLENOSPHERE, 36MM
• 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: 13052856
• MDR Text Key: 282575776
• Report Number: 1038671-2021-00716
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862534934
• UDI-Public: 10885862534934
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-31-36
• Device Catalogue Number: 320-31-36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2022
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 53 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White