MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 46MM HUMERAL LINER +2.5

Model Number	320-46-03
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The revision reported was likely the result of incomplete seating of the humeral liner during the second revision, patient conditions involving two previous revisions due to humeral liner disassociation, or a combination of the two, which led to the humeral liner disassociating from the humeral tray.However, this cannot be confirmed as the devices were not available for evaluation.Concomitant device(s): 300-30-06, 6704501 - equinoxe preserve stem 6mm.320-10-00, 6653475 - equinoxe reverse tray adapter plate tray +0.320-01-46, 4644437 - equinoxe reverse 46mm glenosphere.
Event or Problem Description
As reported, approximately 5 weeks postop a right shoulder revision, the surgeon revised the (b)(6) y/o male patient's right shoulder due to the liner separating from the humeral tray sometime after the patient had his revision surgery.Dr.(b)(6) removed a 46 glenosphere, a 46 +2.5 humeral liner, an adaptor tray and a preserve stem.He revised the glenoid side with a 42 +4mm glenosphere.Patient was last known to be in stable condition following the event.Devices are not returning due to facility policy.

• Brand Name: EQUINOXE
• Common Device Name: REVERSE 46MM HUMERAL LINER +2.5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11695153
• Report Number: 1038671-2021-00181
• Device Sequence Number: 3073218
• 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 Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/20/2021

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: 320-46-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2021
• Initial Report FDA Received Date: 04/20/2021
• 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: 74 YR
• Patient Weight: 94