MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE 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 Code	Insufficient Information (4580)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 69 yo male patient who had a right rtsa, underwent a revision procedure approximately 2 years 8 months post the prior procedure.The poly liner dissociated from the tray was reported.The glenosphere, liner, and tray were revised.There was device breakage reported but no parts or pieces fell into the wound site.The dissociated tray was removed.There were no surgical delays reported.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 as they were discarded.No photos were able to be obtained.An earlier revision had occurred to address instability.No further information.This is 1 of 2 reports for this event, this is 1 of 2 events for this patient.
Additional Manufacturer Narrative
D10: 11018121008 a10012 - gps implant kit v2, (b)(6), 320-01-38 - equinoxe reverse 38mm glenosphere, (b)(6), 320-15-02 - rs glenoid plate sup aug, 10 deg, (b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, (b)(6), 300-30-08 - equinoxe preserve stem 8mm, (b)(6), 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, (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), 320-10-00 - equinoxe reverse tray adapter plate tray +0, (b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, (b)(6), 320-15-05 - eq rev locking screw, (b)(6), 320-20-00 - eq reverse torque defining screw kit, (b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, (b)(6), 531-20-00 - shldr gps rvrs drill kit, (b)(6), 320-38-03 - equinoxe reverse 38mm humeral liner +2.5.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.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.A review of manufacturing data was performed, and no discrepancies were found.A review of complaint history determined that no further action is required as no trends were identified.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 images/radiographs were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE 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 32653 ; 3525541928
• MDR Report Key: 23459349
• Report Number: 1038671-2025-03262
• Device Sequence Number: 13021855
• Product Code: KWT
• UDI-Device Identifier: 10885862086723
• UDI-Public: 10885862086723
• 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: 2023
• 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): 02/18/2026

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 Expiration Date: 01/04/2026
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2018
• 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; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male