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

Model Number EQUINOXE CAGE GLENOID M, POST AUG, RIGHT

Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 04/11/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer? pending evaluation.Concomitant medical device(s): humeral stem, 9mm (cat# 300-01-09 / sn# (b)(4)).Anatomic replicator plate (cat# 300-10-15/ sn# (b)(4)).Humeral head t 44mm (cat# 310-02-44 / sn# (b)(4)).

Event Description

It was reported that the patient was revised from anatomic tsr to reverse due to suspected glenoid loosening.Upon removing component, the central peg appeared to be sheared off (could have happened during removal) and there were signs of wear on the poly.Unable to confirm if component was loosened.

Manufacturer Narrative

The revision reported may have been the result of drilling the central cage hole at an angle or not fully seating the cage glenoid component at the time of implantation, which led to the disassociation of the cage from the polyethylene body of the glenoid component, and/or an insufficient bond between the implant and the bone which may have led to aseptic (non-infected) loosening of the glenoid.However, this cannot be confirmed because the component was not returned for evaluation and x-rays were not provided.

• Brand Name: EQUINOXE
• Type of Device: CAGE GLENOID M, POST AUG, RIGHT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9322232
• MDR Text Key: 166382464
• Report Number: 1038671-2019-00567
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862201010
• UDI-Public: 10885862201010
• Combination Product (y/n): N
• PMA/PMN Number: K113309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2020
• Device Model Number: EQUINOXE CAGE GLENOID M, POST AUG, RIGHT
• Device Catalogue Number: 314-13-33
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR