MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 46MM GLENOSPHERE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE REVERSE 46MM GLENOSPHERE
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products - equinoxe reverse tray adapter plate tray +5 (cat# 320-10-05 / serial# (b)(6) ).- eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(6) ).- equinoxe reverse 42mm humeral liner +0 (cat# 320-42-00 / serial# (b)(6) ).- eq rev locking screw (cat# 320-15-05 / serial# (b)(6) ).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 1.5 years post initial right tsa, the 60 y/o male patient was revised due to dislocation.The patient was revised to a 42mm, +4mm expanded glenosphere and a 42mm liner.The torque screw kit, adapter tray and locking screw were also revised.There was no breakage of device or surgical delay/prolongation patient was last known to be in stable condition following the event.The sales rep was unable to obtain photos/x-rays.The devices are not available for evaluation due to hospital did not return.No other patient information/medical history reported.
Additional Manufacturer Narrative
H3: the dislocation reported may have been due to positioning of the components at the time of implantation, mechanical impingement, joint tensioning, or an unreported traumatic event.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the dislocation and subsequent revision cannot be conclusively determined.
Additional Manufacturer Narrative
H6: corrected medical device problem code.Manufacturer narrative updated: based on review of all available information, there is no evidence to suggest that the reported event is related to any product problems or use issues.The cause of the dislocation cannot be conclusively determined; however, the reported dislocation may have been related to several potential factors including but not limited to the implant selection, the surgical procedure itself, patient anatomical issues, patient activity after surgery and/or underlying patient medical conditions.

• Brand Name: EQUINOXE REVERSE 46MM GLENOSPHERE
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: michael crader
• MDR Report Key: 18946343
• Report Number: 1038671-2024-00596
• Device Sequence Number: 18155641
• Product Code: KWT
• UDI-Device Identifier: 10885862086402
• UDI-Public: 10885862086402
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2024

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 Model Number: EQUINOXE REVERSE 46MM GLENOSPHERE
• Device Catalogue Number: 320-01-46
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/16/2024; 10/08/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 08/22/2024; 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2018
• 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: EQUINOXE HUMERAL LONG STEM 10MM 200MM; RS GLENOID PLATE POST AUG, 8 DEG, RIGHT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male