MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; SUP/POST AUG PLATE, R RS GLENOID BASEPLATE

Catalog Number 320-15-08

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 07/24/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant devices: 320-01-42, 42mm glenosphere; 320-42-00, 42mm humeral liner; 320-20-38, 38mm screw; 320-20-46, 46mm screw; 320-20-00, reverse torque screw; 320-15-05, reverse glenosphere locking screw; 320-10-00, 0+ tray.

Event Description

Revision due to the patient¿s glenoid breaking.

Manufacturer Narrative

Section h10: (e3) occupation: physician (g5) pma/510(k)number: k131575 (h3) the revision reported was likely the result of a combination of an insufficient bond between the glenoid baseplate and the bone and the patient¿s bone quality, which led to aseptic (non-infected) glenoid loosening.However, this cannot be confirmed as the devices were not available for evaluation.No information provided in the following section(s): a3, a5, b6, b7, d6, d7, g8, h4, h6, h7.

• Brand Name: EQUINOXE
• Type of Device: SUP/POST AUG PLATE, R RS GLENOID BASEPLATE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8859626
• MDR Text Key: 153246441
• Report Number: 1038671-2019-00389
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862242563
• UDI-Public: 10885862242563
• Combination Product (y/n): N
• PMA/PMN Number: K131575
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

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: Health Professional
• Device Catalogue Number: 320-15-08
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/05/2019
• Supplement Dates Manufacturer Received: 10/07/2019
• Supplement Dates FDA Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 45