MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 42MM GLENOSPHERE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-01-42
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Crepitus (4893)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 67 yo male patient who had an initial right tsa implanted, underwent a revision procedure approximately 4 years 10 months post the initial procedure.The patient was indicated for surgery due to ¿clunking¿ feeling in shoulder, followed by loss of function.X-ray revealed that the glenosphere locking screw had disengaged from the glenosphere, which was still seated correctly on the baseplate, and was floating in the joint space.The polyethylene liner was not visible between the humeral adaptor tray and glenosphere, which were in contact, suggesting it has disassociated from the humeral adaptor tray.During surgery, significant metalosis of surrounding soft tissue was noted.Glenosphere screw was removed from the joint space, and polyethylene liner was confirmed to have disassociated from the humeral adaptor tray, which was damaged due to contact with the glenosphere.Polyethylene liner was severely damaged due to contact with the glenosphere locking screw.All affected implants, (liner, adaptor tray, glenosphere and screw) where replaced like for like.There was device breakage during the procedure, parts and pieced did fall into the wound site but were removed by the surgeon.There was less than a 5 minute surgical delay with no impact to patient during the procedure.The patient was last known to be in stable condition following the event.No x-rays were able to be obtained.The explanted devices are not available for return.The hospital is retaining them for analysis.Device images were provided.No further information.This is 1 of 5 reports for this incident.
Additional Manufacturer Narrative
D10 300-01-17 - equi hum stem primary press fit 17mm: (b)(6).320-02-42 - rs exp glen 42mm, +4mm offset: (b)(6).320-20-00 - eq rev torque defining screw kit: (b)(6).320-20-22 - eq rev comp scr lck cap kit, 4.5 x 22mm: (b)(6).320-20-26 - eq rev comp scr lck cap kit, 4.5 x 26mm: (b)(6).320-20-26 - eq rev comp scr lck cap kit, 4.5 x 26mm: (b)(6).320-20-30 - eq rev comp scr lck cap kit, 4.5 x 30mm: (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3, h6, h11.A comprehensive review of all pertinent records was conducted.Engineering evaluation noted the revision reported was likely the result of humeral liner disassociation and locking screw disassembly leading to wear of the humeral liner and subsequent metal-on-metal articulation between the humeral tray and glenosphere.Locking screw disassembly cannot be confirmed but potential causes may be related to improper initial seating of the glenosphere, an unreported traumatic event, bone/soft tissue interposition, and/or breakage of the central locking screw.Potential contributions from patient conditions, an unreported traumatic event, incomplete seating of the humeral liner during implantation, forceful contact between the liner and glenoid bone (scapular notching), or a combination of the above to the disassembly of the humeral liner cannot be confirmed as the devices were not returned for evaluation and radiographs were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE REVERSE 42MM 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: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 23576421
• Report Number: 1038671-2025-03350
• Device Sequence Number: 18517845
• Product Code: KWT
• UDI-Device Identifier: 10885862086396
• UDI-Public: 10885862086396
• 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: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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 Catalogue Number: 320-01-42
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male