MAUDE Adverse Event Report: EXACTECH, INC EQUINOXE STEM, 9MM

Catalog Number 300-01-09

Device Problem Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Complaint, Ill-Defined (2331)

Event Date 08/27/2015

Event Type  Injury  

Manufacturer Narrative

Pending engineering evaluation.

Event Description

The patient is reported to have developed tumors and cysts on her back and shoulder near the surgical site.

Manufacturer Narrative

Engineering evaluation noted that the revision reported was likely the result of scapular notching, which led to wear of the humeral liner and osteolysis around the glenosphere.

Event Description

The patient is reported to have developed tumors and cysts on her back and shoulder near the surgical site.

• Brand Name: EQUINOXE STEM, 9MM
• Type of Device: STEM
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 5184673
• MDR Text Key: 29731714
• Report Number: 1038671-2015-00621
• 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: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 300-01-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other