MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL STEM PRIMARY, PRESS FIT 15MM

Model Number 300-01-15

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.

Event Description

As reported, during impaction phase of the procedure on this (b)(6) y/o male patient, the implant, broach trial, and reamer for a size 15 did not match sizes and surgeon ended up having a subsided stem."specifically trial and real implant." the surgeon had to ream the canal again and broach up a size in order to get implant to fit.Created a stressful situation for surgeon.This created a short delay with no harm to the patient.Patient was last known to be in stable condition following the event.Device to return.

Manufacturer Narrative

Section h10: h3: the size discrepancy reported was likely the result of the stem trail's distal diameter being manufactured at mmc and proximal m/l width being undersized while the final implant's distal diameter being manufactured closer to lmc, which led to the stem trial sitting proud and the final implant subsiding.Additional contributing factor may include user error or over impacting when broaching the humerus or poor bone quality.

• Brand Name: EQUINOXE
• Type of Device: HUMERAL STEM PRIMARY, PRESS FIT 15MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11404350
• MDR Text Key: 235006711
• Report Number: 1038671-2021-00084
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862079336
• UDI-Public: 10885862079336
• Combination Product (y/n): N
• PMA/PMN Number: K042021
• 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: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 300-01-15
• Device Catalogue Number: 300-01-15
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR