MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID LARGE, BETA; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE CAGE GLENOID LARGE, BETA
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Naturally Worn (2988); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	01/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient, initial right shoulder implanted on (b)(6)2014, underwent a revision procedure on (b)(6)2024, approximately 9 years 10 months post the initial procedure.The patient presented with complaints of pain.The glenoid component had migrated from its original position.Significant wear and osteolysis found.Bone grafting and conversion to reverse was performed.There were no issues with the surgery.X-rays were provided.Explanted devices are not available for return.Device images were provided.No further information.
Additional Manufacturer Narrative
Concomitants: 2532751-310-01-53 - equinoxe, humeral head short, 53mm (beta).2719489-300-01-15 - equinoxe, humeral stem primary, press fit 15mm.2770139-314-13-14 - equinoxe cage glenoid large, beta.2840008-300-10-15 - equinoxe replicator plate 1.5mm o/s.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
The reason for the revision reported was likely the result of prosthesis wear.Additional reasons for the reported revision may be migration and inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation.D1: corrected.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: EQUINOXE CAGE GLENOID LARGE, BETA
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18803637
• Report Number: 1038671-2024-00336
• Device Sequence Number: 7248685
• Product Code: KWT
• UDI-Device Identifier: 10885862172716
• UDI-Public: 10885862172716
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: 08/01/2018
• Device Model Number: EQUINOXE CAGE GLENOID LARGE, BETA
• Device Catalogue Number: 314-13-14
• 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: 03/25/2025
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 03/25/2025
• Date Device Manufactured: 08/02/2013
• 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: Required Intervention
• Patient Sex: Unknown