MAUDE Adverse Event Report: EXACTECH, INC EQUINOXE REVERSE HUMERAL ADAPTER TRAY

Catalog Number 320-10-10

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 10/17/2016

Event Type  Injury  

Manufacturer Narrative

Pending engineering evaluation.Device not returned.

Event Description

Revision due to humeral tray dissociation.Implanted less than 2 weeks.

Manufacturer Narrative

Engineering evaluation noted that the revision reported was likely the result of the humeral tray not fully seating during the initial implantation, possibly due to the presence of bone cement on top of the humerus, which led to insufficient thread engagement to the humeral stem.

Event Description

Revision due to humeral tray dissociation.Implanted less than 2 weeks.

• Brand Name: EQUINOXE REVERSE HUMERAL ADAPTER TRAY
• Type of Device: REVERSE HUMERAL ADAPTER TRAY
• 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: 6026015
• MDR Text Key: 57296120
• Report Number: 1038671-2016-00667
• 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: 02/24/2017

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: 320-10-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 10/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention