MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PRESERVE STEM 6MM

Model Number 300-30-06

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Pain (1994)

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation; concomitant device(s): 300-20-02, 5845997; equinox square torque define screw drive kit; 314-13-13, 6088098; equinoxe cage glenoid medium, beta; 310-02-50, 6074030; equinoxe, humeral head tall, 50mm (beta); 300-10-15, 5766891; equinoxe replicator plate 1.5mm o/s; 321-20-00, 5595330; equinoxe reverse shoulder drill kit.

Event Description

As was reported, approximately 1 year postop the initial right tsa due to arthritis, this (b)(6) y/o male completed his postop rehab.The patient then presented to another physician with rt shoulder pain, where an x-ray found the stem was sitting high, head was oversized, and the stem was found to be varus.It was reported that, ¿an intra-op x-ray done at the time of completing the initial surgery, looked clinically excellent.¿ this surgeon did suggest functionally a reverse would be optimal and patient refused.A standard revision was scheduled, and completed.Patient was last known to be in stable condition, following the event.Devices were disposed by the hospital.

Manufacturer Narrative

Section h10: (h3) the revision reported is most likely secondary to improper sizing and positioning of the implants that resulted in the reported pain and rotator cuff tear from over-tensioning of the shoulder joint.

• Brand Name: EQUINOXE
• Type of Device: PRESERVE STEM 6MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10841093
• MDR Text Key: 216313747
• Report Number: 1038671-2020-00617
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862515742
• UDI-Public: 10885862515742
• Combination Product (y/n): N
• PMA/PMN Number: K162726
• 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: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 300-30-06
• Device Catalogue Number: 300-30-06
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR