MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; CAGE GLENOID

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

This event report was received through clinical data collection activities.Pending evaluation.Concomitant devices: torque screw (cn: not reported; sn: not reported).Replicator plate (cn: not reported; sn: not reported).Humeral head (cn: not reported; sn: not reported).

Event Description

Primary surgery: (b)(6) 2013.Revision due to subscapularis failure 5 years post-op.The case report form indicates this event is definitely not related to devices and definitely related to procedure.The case report form indicates this event was resolved with revision surgery.

Manufacturer Narrative

The revision reported was likely the result of a rotator cuff tear.A review of the dhr and the sterilization records was not conducted because the event as described does not appear to be related to the design, manufacturing, or reasonably foreseeable misuse of the device.¿soft tissue damage which may lead to a second surgical intervention or revision¿ is listed in the total joint surgery risks section of the equinoxe shoulder system ifu 700-096-060 rev.M.As stated in the ifu for equinoxe (700-096-060 rev.M), ¿the equinoxe reverse shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.¿.

• Brand Name: EQUINOXE
• Type of Device: CAGE GLENOID
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8707365
• MDR Text Key: 148284582
• Report Number: 1038671-2019-00327
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/30/2019
• Date Manufacturer Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention
• Patient Weight: 96