MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL STEM PRIMARY, PRESS FIT 15MM

Model Number	320-02-42
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, this (b)(6) y/o female patient was previously revised on (b)(6) 2020 for with a loose humeral component from a suspected infection.Currently, patient's stem is loose.Removed humeral components as well as glenosphere, locking screw and compression screws.Replaced all shoulder components.The patient has a bmi of 50+.Patient was last known to be in stable condition following the event.Devices will not return due to facility policy.
Additional Manufacturer Narrative
Device evaluated by manufacturer? pending evaluation.Concomitant medical device(s): 300-01-15, (b)(4) - equinoxe, humeral stem primary, press fit 15mm; 320-10-00, (b)(4) - equinoxe reverse tray adapter plate tray +0; 320-15-05, (b)(4) - eq rev locking screw; 320-20-00, (b)(4) - eq reverse torque defining screw kit; 320-42-10, (b)(4) - equinoxe reverse 42mm humeral const liner +0; 320-20-38, (b)(4) - eq rev compress screw lck cap kit, 4.5 x 38mm; 320-20-38, (b)(4) - eq rev compress screw lck cap kit, 4.5 x 38mm.
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of both patient-related conditions and an insufficient bond between the humeral stem and the bone, which led to aseptic (non-infected) humeral loosening.However, this cannot be confirmed as the devices and x-rays were not available for evaluation.Section h11: *the following sections have corrected information: (d2b) common device name: humeral stem primary, press fit 15mm (d4) catalog number: 300-01-15, serial number: (b)(6), expiration date: 10-jan-2029, unique identifier (udi) #: (b)(4).(d11) concomitant device(s): 320-10-00, 6622588 - equinoxe reverse tray adapter plate tray +0.320-15-05, 6610420 - eq rev locking screw.320-20-00, 6624065 - eq reverse torque defining screw kit.320-42-10, 6136285 - equinoxe reverse 42mm humeral const liner +0.320-20-38, 6022248 - eq rev compress screw lck cap kit, 4.5 x 38mm.320-20-38, 6044687 - eq rev compress screw lck cap kit, 4.5 x 38mm.320-02-42, 6528863 - rs expanded glenosphere 42mm, +4mm offset.(g4) pma/510(k)number: k042021.(h4) device manufacture date: 12-jan-2019.

• Brand Name: EQUINOXE
• Common Device Name: HUMERAL STEM PRIMARY, PRESS FIT 15MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 13003206
• Report Number: 1038671-2021-00692
• Device Sequence Number: 4829673
• Product Code: KWT
• UDI-Device Identifier: 10885862079336
• UDI-Public: 10885862079336
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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: 320-02-42
• Device Catalogue Number: 300-01-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 50 KG