MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM

Catalog Number 300-01-09

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 10/05/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision due to infection.

Manufacturer Narrative

The revision reported was likely the result of infection.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM
• Type of Device: STEM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th court; gainesville FL 23653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 8008857
• MDR Text Key: 125113599
• Report Number: 1038671-2018-00837
• 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: 10/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 300-01-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 70