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

Catalog Number 300-01-15

Device Problem Microbial Contamination of Device (2303)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Dr.(b)(6) revised a shoulder that was infected and the patient was complaining of pain.The patient's health was stable as they left the o.R.

Manufacturer Narrative

The revision reported was likely the result of infection, which led to pain.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM
• Type of Device: STEM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 8120568
• MDR Text Key: 128917238
• Report Number: 1038671-2018-00906
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 300-01-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 128