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

Catalog Number	320-15-08
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/24/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Revision due to the patient¿s glenoid breaking.
Additional 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
• Common Device Name: SUP/POST AUG PLATE, R RS GLENOID BASEPLATE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8859626
• Report Number: 1038671-2019-00389
• Device Sequence Number: 526072
• Product Code: KWT
• UDI-Device Identifier: 10885862242563
• UDI-Public: 10885862242563
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 320-15-08
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 45