MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; CAGE GLENOID LARGE, BETA

Catalog Number 314-13-14

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 08/28/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer? pending evaluation.Concomitant medical device(s): humeral stem or stemless (cat# 300-01-13).Humeral head (cat# 310-01-53).Replicator plate (cat# 300-10-45).

Event Description

As reported by the (b)(6) study, the (b)(6) y/o male, (b)(6) lbs, 5¿9¿ tall, patient presented with complete polyethylene dissociation consistent with subscapularis tear on (b)(6) 2019.Revision due to aseptic glenoid loosing was completed on (b)(6) 2019.The patient¿s shoulder was converted from standard total to hemiarthroplasty, removed all glenoid components-severe metallosis about the glenoid cage.The study report states the event is unlikely related to the device and related to the procedure.All information has been received at this time.Patient has history of osteoarthritis, hypertension, diabetic, and previous steroid injections.

Manufacturer Narrative

The revision reported was likely the result of the subscapularis tear, which led to glenoid disassociation.The surgeon¿s decision to convert from a reverse total shoulder to a hemiarthroplasty indicates that the patient¿s bone quality was too poor to support new glenoid components.

• Brand Name: EQUINOXE
• Type of Device: CAGE GLENOID LARGE, BETA
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9519291
• MDR Text Key: 189045148
• Report Number: 1038671-2019-00621
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862172716
• UDI-Public: 10885862172716
• 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: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 314-13-14
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 115