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

Model Number 314-13-03

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Osteopenia/ Osteoporosis (2651)

Event Date 09/25/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 4.5 replicator plate (cat# 300-10-45 / sn# (b)(4)), torque defining screw kit (cat# 300-20-02 / sn# (b)(4)), humeral head 44 mm tall (cat# 310-02-44 / sn# (b)(4)).

Event Description

It was reported that the original case xrays revealed a failed caged glenoid.The pegs had been disassociated but the cage remained in bone.The surgeon decided to convert this patient to a reverse.The humeral head, replicator plate and caged glenoid came out using the appropriate removal tools and technique.Poor bone quality was noted by surgeon.A posterior augmented caged glenoid baseplate was put in with 6 screws.Surgeon noted that none of the screws had very good bite in the bone.A 42 mm glenosphere was placed and when an attempt to trial was made on the humeral side the entire baseplate/screws/glenosphere came out of the patient with some glenoid bone.Surgeon stated it was the bone quality and nothing from our implants.He then chose to place a large humeral head on still solid stem and leave as a hemi.Patient left stable and is expected to do well.

Manufacturer Narrative

Section h10: (b2) outcomes attributed to adverse event: added check for required intervention to prevent permanent impairment/damage (devices) and hospitalization - initial or prolonged (h3) the revision reported was likely the result of a patient condition due to poor bone quality as reported by the surgeon, which led to the disassociation of central cage from the polyethylene body and of the peripheral pegs/sleeves from the bone.

• Brand Name: EQUINOXE
• Type of Device: CAGE GLENOID MEDIUM, ALPHA
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9191994
• MDR Text Key: 162668795
• Report Number: 1038671-2019-00503
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862172686
• UDI-Public: 10885862172686
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2019
• Device Model Number: 314-13-03
• Device Catalogue Number: 314-13-03
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/15/2019
• Supplement Dates Manufacturer Received: 03/27/2020
• Supplement Dates FDA 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: 70 YR