MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL HEAD

Catalog Number 310-01-44

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

Event Date 01/07/2015

Event Type  malfunction  

Event Description

The surgeon reported that he implanted a 47 mm head (from measurements made from the x-ray) even though he wanted to implant a 44 mm humeral head.The implant label stated it was a 44 mm humeral head.The humeral head was measured on the provided x-ray and it does not measure 44 mm.

Manufacturer Narrative

Pending engineering evaluation.

• Brand Name: EQUINOXE HUMERAL HEAD
• Type of Device: HUMERAL HEAD
• Manufacturer (Section D): EXACTECH, INC.; 2320 n.w. 66th ct.; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 n.w. 66th ct.; gainesville, FL 32653
• MDR Report Key: 4478025
• MDR Text Key: 5327000
• Report Number: 1038671-2014-00733
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 310-01-44
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention