MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE PRESERVE STEM 10MM

Model Number	300-30-10
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event report was received through clinical data collection activities.Pending evaluation.Concomitant devices: reverse humeral liner (cn: 320-38-00).Reverse humeral tray (cn: 320-10-05).Reverse glenosphere (cn: 320-01-38).Reverse glenosphere baseplate (cn: 320-15-04).Screws x4 (cn: not reported).
Event or Problem Description
Index surgery: (b)(6) 2019.X-rays show stem subsidence.No action was taken.The case report form indicates the event is possibly related to devices and possibly related to procedure.
Additional Manufacturer Narrative
(a2) age at the time of even: 60 years.(b2) outcomes attributed to adverse event: added check for hospitalization - initial or prolonged.(b7) other relevant history, including preexisting medical conditions: patient has osteoarthritis.(d4) expiration date: 09-sep-2028, serial number: (b)(6).(e3) occupation: physician.(g5) pma/510(k)number: k162726.(h3) the subsidence reported was likely the result of either under sizing the humeral stem or insufficient bony support for the implant.However, this cannot be confirmed because the component was not returned for evaluation.(h4) device manufacture date: 11-sep-2018.The following sections have corrected information: (d11) concomitant device(s): equinoxe reverse 38mm humeral liner +0 (cn: (b)(4), sn: (b)(6).Equinoxe reverse tray adapter plate tray +5 (cn: (b)(4), sn: (b)(6).Equinoxe reverse 38mm glenosphere (cn: (b)(4), sn: (b)(6).Rs glenoid plate r post aug, 8 deg, right (cn: (b)(4), sn: (b)(6).Eq rev compress screw lck cap kit, 4.5 x 38mm (cn: (b)(4), sn: (b)(6).Eq rev compress screw lck cap kit, 4.5 x 42mm (cn: (b)(4), sn: (b)(6).Eq rev compress screw lck cap kit, 4.5 x 34mm (cn: (b)(4), sn: (b)(6).Eq rev compress screw lck cap kit, 4.5 x 34mm (cn: (b)(4), sn: (b)(6).(section f) please disregard f6 and f8.These were entered in error.(g4) initial awareness date in initial submission should have been 09-jun-2019.(h1) type of reportable event: serious injury.

• Brand Name: EQUINOXE
• Common Device Name: EQUINOXE PRESERVE STEM 10MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8756365
• Report Number: 1038671-2019-00354
• Device Sequence Number: 13838310
• Product Code: KWT
• UDI-Device Identifier: 10885862515780
• UDI-Public: 10885862515780
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 300-30-10
• Device Catalogue Number: 300-30-10
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/09/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE. H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 98