MAUDE Adverse Event Report: EXACTECH INC. EQUINOXE HUMERAL STEM

Device Problem Positioning Problem (3009)

Patient Problems Pain (1994); Reaction (2414)

Event Date 01/13/2014

Event Type  Other  

Event Description

Revision of equinoxe shoulder components due to reports of pain.Surgeon noted that the humeral liner was not sufficiently secured to the adapter tray and the resulting polyethylene wear is believed to have caused the stem to become loose and for the tissue to have a reaction.

Manufacturer Narrative

Devices are pending engineering evaluation and review of the device history record.

• Brand Name: EQUINOXE HUMERAL STEM
• Type of Device: HUMERAL STEM
• Manufacturer (Section D): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th court; gainesville, FL 32653 ; 8003922832
• MDR Report Key: 3641708
• MDR Text Key: 4353894
• Report Number: 1038671-2014-00027
• 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: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention