MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 42MM CONST HUM LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-42-13
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	11/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 320-10-05 - equinoxe reverse tray adapter plate tray +5 (b)(6), 320-20-00 - eq reverse torque defining screw kit (b)(6), 320-20-00 - eq reverse torque defining screw kit (b)(6), 320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm (b)(6), 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm (b)(6), 320-15-04 - rs glenoid plate post aug, 8 deg, right (b)(6), 320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm (b)(6), 300-01-15 - equinoxe, humeral stem primary, press fit 15mm (b)(6), 315-35-00 - glnd kwire (b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm (b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm (b)(6), 320-01-42 - equinoxe reverse 42mm glenosphere (b)(6), 315-35-00 - glnd kwire (b)(6), 320-15-05 - eq rev locking screw (b)(6), 321-20-00 - equinoxe reverse shoulder drill kit (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was report that male patient who had a right rtsa that was revised due to a fall, underwent a second revision approximately 2 months post the prior revision.A constrained liner was put in due to unavailability of standard 42mm liner (international recall) during the prior procedure.A couple months later, the constrained liner disengaged from the humeral tray while the patient was performing daily activity.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.X-ray images were provided.The explanted devices are not available for return as they were discarded.No device images provided.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3, h6, h11.No device was returned for evaluation; radiograph images were provided; however, the reported event was unable to be confirmed.The review of pre-revision radiographs identified that the glenosphere could potentially be abnormally articulating against the posterior aspect of the humeral tray.This may be an indicator for humeral liner disassociation; however, it cannot be confirmed based on the angle of the radiograph.All other aspects of the radiograph appear unremarkable for implanted components.A review of complaint history determined that no further action is required as no trends were identified.A review of manufacturing data was performed and no discrepancies were found.The revision reported was likely the result of disassembly between the humeral liner and humeral tray.However, this cannot be confirmed and 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 reported disassembly of the humeral liner cannot be determined as the devices were not returned for evaluation and product images were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: 145-DEG PE 42MM CONST HUM 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 23812663
• Report Number: 1038671-2025-03553
• Device Sequence Number: 10066934
• Product Code: KWT
• UDI-Device Identifier: 10885862086723
• UDI-Public: 10885862086723
• 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: 2025
• 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): 02/27/2026

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: 320-42-13
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male