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

Model Number	EQUINOXE CAGE GLENOID LARGE, BETA
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient, initial shoulder implanted on (b)(6) 2016, underwent a revision procedure on (b)(6) 2023, approximately 7 years 8 months post the initial procedure.The patient had presented with pain.The glenoid component was stable but was removed easily except the central cage remained in the bone.A trephine reamer and thread in extractor were used to remove the glenoid.Significant wear of the glenoid was visually confirmed prior to its removal.The stem was planned to be kept, but was found to be loose, so removal was performed and a conversion to a competitor¿s components was done with significant bone grafting on glenoid.There were no issues with the surgery.X-rays and device images provided.Explants are not available for return.Reason unknown.No further information.
Additional Manufacturer Narrative
Concomitants: 3885932 300-01-13 - equinoxe, humeral stem primary, press fit 13mm.4100198 300-10-45 - equinoxe replicator plate 4.5mm o/s.4238199 300-20-02 - equinox square torque define screw drive kit.2832614 310-01-50 - equinoxe, humeral head short, 50mm (beta).4245253 321-20-00 - equinoxe reverse shoulder drill kit.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/or corrected information.The following sections were updated/corrected: b3, d1, h6.Mdr section codes updated/corrected: a, b, c, d, g.The reason for the revision cannot be confirmed but may have been due to an insufficient bond between the glenoid component and the bone and/or the humeral component and the bone leading to aseptic (non-infected) loosening of the glenoid and humeral components respectively, reported wear of the glenoid component, and/or the inclusion of the polyethylene in the packaging recall.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a patient, initial shoulder implanted, underwent a revision procedure, approximately seven years eight months post the initial procedure.The patient had presented with pain.The glenoid component was stable but was removed easily except the central cage remained in the bone.A trephine reamer and thread in extractor were used to remove the glenoid.Significant wear of the glenoid was visually confirmed prior to its removal.The stem was planned to be kept, but was found to be loose, so removal was performed and a conversion to a competitor¿s components was done with significant bone grafting on glenoid.There were no issues with the surgery.X-rays and device images provided.Explants are not available for return.Reason unknown.No further information.

• Brand Name: EQUINOXE CAGE GLENOID LARGE, BETA
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 18012426
• Report Number: 1038671-2023-02613
• Device Sequence Number: 15320736
• Product Code: KWS
• 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: 2016
• Device Explanted Year: 2023
• 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): 10/27/2025

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: 09/27/2020
• 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: 10/03/2023
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2015
• 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