MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 46MM HUMERAL LINER +0

Model Number	320-46-03
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 320-10-05, equinoxe reverse tray adapter plate tray +5.320-02-46, 46x21mm glenosphere high moment arm.300-30-06, equinoxe preserve stem 6mm.
Event or Problem Description
As reported, this (b)(6) y/o male patient's left shoulder dislocated sometime after his initial surgery.The surgeon had to revise the patient's shoulder due to the liner separating from the humeral tray sometime after initial surgery.The surgeon removed a 46 inset glenosphere, 46 neutral liner, +5mm adapter tray and a size 6 preserve stem.He replaced them with a 42 +4mm glenosphere, 42 +2.5 humeral liner, +5mm adapter tray and a size 10 preserve stem.Patient was last known to be in stable condition following the event.Device to be returned.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of a combination of the dislocation and the humeral liner disassociation.It is unclear if the dislocation allowed for the humeral liner to disassociate or if the humeral liner disassociation led to the dislocation, which may have been the result of either incomplete seating of the liner during implantation, patient conditions, or a combination of the two.

• Brand Name: EQUINOXE
• Common Device Name: REVERSE 46MM HUMERAL LINER +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11618091
• Report Number: 1038671-2021-00153
• Device Sequence Number: 14275543
• Product Code: KWT
• UDI-Device Identifier: 10885862086747
• UDI-Public: 10885862086747
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/12/2021

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: 07/05/2025
• Device Model Number: 320-46-03
• Device Catalogue Number: 320-46-00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 05/12/2021
• 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: 66 YR
• Patient Weight: 91