MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 38MM HUMERAL CONST LINER +0

Model Number	320-38-10
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant device(s): 320-15-05, 6053781 - eq rev locking screw; 320-01-38, 6068866 - equinoxe reverse 38mm glenosphere.
Event or Problem Description
As reported, approximately 3 years post op the initial left tsa, this (b)(6) male patient was revised due to dissociation of the liner from the tray while lifting dog cages.Patient was on vacation in (b)(6) two weeks ago.While lifting dog cages he felt a pop in the shoulder followed by pain an inability to rotate the arm easily.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Devices have been returned.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported may have been the result of either incomplete seating of the liner during implantation, bone impingement, patient-related conditions, a post traumatic event, or any combination of these possibilities, which led to humeral liner disassociation.Section h11: the following sections have corrected information: (h6) component code: 4755, part/component/sub-assembly term not applicable.

• Brand Name: EQUINOXE
• Common Device Name: REVERSE 38MM HUMERAL CONST LINER +0
• 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: 14012836
• Report Number: 1038671-2022-00367
• Device Sequence Number: 5229883
• Product Code: KWT
• UDI-Device Identifier: 10885862086679
• UDI-Public: 10885862086679
• 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: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2022

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 Expiration Date: 09/17/2022
• Device Model Number: 320-38-10
• Device Catalogue Number: 320-38-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 82 KG