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

Catalog Number 320-10-05

Device Problems Material Disintegration (1177); Migration (4003)

Patient Problems Joint Disorder (2373); No Known Impact Or Consequence To Patient (2692)

Event Date 08/10/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision due to the humeral adapter tray disassociating from the humeral stem.

Event Description

It was reported that a patient had revision due to the humeral adapter tray disassociating from the humeral stem.The screw remained intact between the humeral liner and tray and the threads on the stem were undamaged.A new adapter tray, liner, and torque screw were implanted with no complications.This is one of three products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00623, and 1038671-2017-00625.

Manufacturer Narrative

Upon review of all available information, the revision due to a humeral tray disassociation reported in experience c2017-468 was likely the result of inadequate seating of the torque screw at the time of initial surgery, which allowed for disassociation of the tray from the stem.Only qualified surgeons knowledgeable in anatomy, biomechanics, and reconstructive surgery should use the devices.The surgeon must be fully knowledgeable about all aspects of the equinoxe surgical technique and use these implants in accordance e with the respective indications and contraindications.In addition, the surgeon should be fully knowledgeable about the compatibility of system components and use each device accordingly.Also, the surgeon must be fully knowledgeable about the surgical technique and they must be trained according to the proper use of the system instrumentation.This device is used for treatment not diagnosis.No information, asked not provided.

• Brand Name: EQUINOXE REVERSE HUMERAL ADAPTER TRAY
• Type of Device: HUMERAL ADAPTER TRAY
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 6812781
• MDR Text Key: 83365974
• Report Number: 1038671-2017-00624
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 320-10-05
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR