MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; 36MM HUMERAL LINER +0 UNCONSTRAINED

Model Number	320-15-06
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The revision reported was likely the result of an insufficient bond between the implants and the bone with led to aseptic (non-infected) loosening of the glenoid baseplate and subsequent pain.However, this cannot be confirmed because the components were not available for evaluation.Concomitant device(s): 320-20-30, 5367104 - eq rev compress screw lck cap kit, 4.5 x 30mm, 320-20-34, 5305677 - eq rev compress screw lck cap kit, 4.5 x 34mm, 320-20-34, 5316874 - eq rev compress screw lck cap kit, 4.5 x 34mm, 320-20-34, 5320326 - eq rev compress screw lck cap kit, 4.5 x 34mm.
Event or Problem Description
As reported by the shoulder clinical study database, approximately 19 mos postop, this (b)(6) y/o female patient presented with increased left shoulder pain.Imaging showed a loose glenoid component and a revision of the humeral tray, liner and glenoid base plate.Resolved date is noted as (b)(6) 2020.The case report form indicates this event is not related to devices or procedure.This event report was received through clinical data collection activities.Devices were not returned.No other information is available at this time.Concomitant devices: 320-10-00, equinoxe reverse tray adapter plate tray +0, 320-15-06, rs glenoid plate ext cag +10mm cage peg.
Additional Manufacturer Narrative
Section h11: *the following sections have corrected information: (d4) catalog number: 320-15-06, serial number: (b)(6).

• Brand Name: EQUINOXE
• Common Device Name: 36MM HUMERAL LINER +0 UNCONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10559676
• Report Number: 1038671-2020-00536
• Device Sequence Number: 11420008
• Product Code: KWT
• UDI-Device Identifier: 10885862186706
• UDI-Public: 10885862186706
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

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 Model Number: 320-15-06
• Device Catalogue Number: 320-15-06
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 09/30/2020
• 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: 60 YR
• Patient Weight: 69