MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL HEAD TALL, 53MM (BETA)

Model Number	310-02-53
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 300-10-45, 29237022 - equinoxe replicator plate 4.5mm o/s.Torque screw.
Event or Problem Description
As reported, approximately 20 days after the initial right tsa on this (b)(6) y/o male patient, the humeral head disassociated from replicator plate.A revision included replacing the replaced 4.5 replicator, torque screw, and 53 mm humeral head.Patient was last known to be in stable condition following the event.Devices will be returned.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of either off-axis impaction or impingement with soft tissue or bone during implantation leading to incomplete engagement of the taper and subsequent disassociation of the humeral head and replicator plate.However, this cannot be confirmed without radiographs from the index procedure.Section h11: *the following sections have corrected information: (d4) serial number: (b)(6), expiration date: 16-dec-2025.(d11) concomitant device(s): 300-20-02, 5906793 - equinox square torque define screw drive kit.300-10-45, 5082349 - equinoxe replicator plate 4.5mm o/s.(h4) device manufacture date: 18-dec-2015.

• Brand Name: EQUINOXE
• Common Device Name: HUMERAL HEAD TALL, 53MM (BETA)
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11404910
• Report Number: 1038671-2021-00087
• Device Sequence Number: 14338899
• Product Code: KWT
• UDI-Device Identifier: 10885862083968
• UDI-Public: 10885862083968
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2021

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: 12/16/2025
• Device Model Number: 310-02-53
• Device Catalogue Number: 310-02-53
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 05/13/2021
• 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: 45 YR
• Patient Weight: 100