MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE REVERSE 38MM HUMERAL LINER +2.5
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately two years post initial right tsa, the 78 y/o male patient¿s implants were revised due to humeral liner dissociation.Patient¿s glenosphere, liner, adapter tray, screw kit and locking screw were revised.There was no breakage of the device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain x-rays or images.The devices are not available for evaluation due to the devices were disposed by the hospital.
Additional Manufacturer Narrative
Section d10: concomitant devices.Equinoxe reverse 38mm glenosphere (cat# 320-01-38 / serial# (b)(6)).Eq rev locking screw (cat# 320-15-05 / serial# (b)(6)).Eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were corrected: h6 clinical coding.The following sections were updated: h6 investigation, findings, and conclusions result of investigation: the revision reported was likely the result of humeral liner disassociation.The reported humeral liner disassociation may have been the result of incomplete seating of the liner during implantation, bone impingement, patient-related conditions, or any combination of these possibilities.However this cannot be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.

• Brand Name: EQUINOXE REVERSE 38MM HUMERAL LINER +2.5
• 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: geoff gannon
• MDR Report Key: 19644976
• Report Number: 1038671-2024-02224
• Device Sequence Number: 7526614
• Product Code: KWT
• UDI-Device Identifier: 10885862086662
• UDI-Public: 10885862086662
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2026
• Device Model Number: EQUINOXE REVERSE 38MM HUMERAL LINER +2.5
• Device Catalogue Number: 320-38-03
• 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: 06/24/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• 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: EQ REV GLENOID PLATE.; EQUINOXE PRESERVE STEM 8MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male