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

Catalog Number	320-15-07
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical device: glenosphere locking screw (cat# 320-15-05 / sn# (b)(4)) ; glenosphere (cat# 320-01-38 / sn# (b)(4)).
Event or Problem Description
It was reported that the revision was due to the glenosphere becoming disassociated from the base plate two months after the initial implant surgery.The surgeon used the superior posterior glenoid plate, a 38 glenosphere and the glenosphere locking screw.He encountered no problem during the first surgery.
Additional Manufacturer Narrative
Section h10: (b2) outcomes attributed to adverse event: added check for hospitalization - initial or prolonged.(e3) occupation: physician.(g3) report source: health professional.(g5) pma/510(k)number: k131575.(h3) the disassembly reported may have been the result of misaligning the glenosphere on the glenoid baseplate during the initial surgery, which may have prevented the glenosphere locking screw from fully seating, allowing for the screw to backout of the baseplate.However, this cannot be confirmed as the devices were not available for evaluation.(h4) device manufacture date: (b)(6) 2015.(h6) evaluation codes: 3165.2907.*no information provided in the following section(s): a3, a4, a5, b6, b7, d6, g8, h7, h9.

• Brand Name: EQUINOXE
• Common Device Name: SUP/POST AUG PLATE, L RS GLENOID BASEPLATE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8969016
• Report Number: 1038671-2019-00446
• Device Sequence Number: 2337019
• Product Code: KWT
• UDI-Device Identifier: 10885862242556
• UDI-Public: 10885862242556
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K131575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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 Expiration Date: 10/05/2025
• Device Catalogue Number: 320-15-07
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 02/06/2020
• 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: 79 YR