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

Catalog Number 300-01-11

Device Problems Loose or Intermittent Connection (1371); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/23/2014

Event Type  malfunction  

Event Description

Patient experienced aseptic glenoid loosening due to a rotator cuff tear.This event report was received through clinical data collection activities.

Manufacturer Narrative

The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.

• Brand Name: EQUINOXE HUMERAL STEM, PRIMARY, PRESS-FIT
• Type of Device: HUMERAL STEM
• 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: 4906670
• MDR Text Key: 6028435
• Report Number: 1038671-2015-00308
• Device Sequence Number: 1
• Product Code: KWT
• 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: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 300-01-11
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/11/2015
• 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: 68 YR