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

Model Number	320-46-00
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 320-01-46, 75199009 - equinoxe reverse 46mm glenosphere.320-10-00, 77234003 - equinoxe reverse tray adapter plate tray +0.
Event or Problem Description
As reported, this (b)(6) y/o male patient¿s right shoulder was revised due to the liner separating from the humeral tray sometime after the initial surgery.The surgeon removed a 46 glenosphere, 46 neutral liner and a +0 adapter tray.He replaced them with a 42+4 glenosphere, 42+2.5 humeral liner and a +10mm adapter tray.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: h3: the revision reported may have been the result of incomplete seating of the humeral liner during implantation, forceful contact between the liner and glenoid bone (scapular notching), extreme wear of the humeral liner, patient conditions, or a combination of the four, which led to the humeral liner disassociating from the humeral tray.However, this cannot be confirmed as the explants not returned for evaluation.Section h11: the following sections have corrected information: (d11) concomitant device(s): 320-01-46, 4474154 - equinoxe reverse 46mm glenosphere.320-10-00, 4685228 - equinoxe reverse tray adapter plate tray +0.

• 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: 11677303
• Report Number: 1038671-2021-00170
• Device Sequence Number: 16906551
• Product Code: KWT
• UDI-Device Identifier: 10885862086730
• UDI-Public: 10885862086730
• 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): 08/03/2021

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: 08/05/2017
• Device Model Number: 320-46-00
• Device Catalogue Number: 320-46-00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/28/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 08/03/2021
• 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: 61 YR
• Patient Weight: 117