MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID XL, POST AUG, RIGHT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-13-35
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 300-62-03 - stemless humeral comp integrip, cage, size 3: (b)(6), 310-62-50 - stemless humeral head 50mm x 16mm x beta: (b)(6), 319-01-32 - steinmann pin sterile 3.2mm x 178mm: (b)(6), 531-20-00 - shldr gps rvrs drill kit: (b)(6), 531-78-20 - shouldr gps hex pins kit: (b)(6), a10012 - gps implant kit v2: (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a 66 yo male patient, who had a right tsa underwent a revision procedure approximately 4 years 11 months post the initial procedure.The patient was revised due to shoulder pain and suspicion of a shoulder infection.During the procedure, the humeral head and stemless humeral component were removed without issue.The glenoid was easy to remove as it was clear there was a mechanical failure of the plastic behind the glenoid in the central cage causing the loosening*.Upon removal of the central cage, the extraction device removed a little over half the length of the center cage.The surgeon couldn't remove the little amount of hardware left without causing additional trauma to the glenoid, so it was left in.All of the peripheral pegs were removed.She was able to perform the reverse tsa and work around the hardware that was still in the glenoid.Once all parts were removed, it was determined that an antibiotic spacer was not necessary, and the surgeon performed a reverse total shoulder using a competitor¿s devices.There was device breakage during the event ¿ the poly peg within the central cage was broken and left in to mitigate further trauma to the glenoid.There were no surgical delays reported.The patient was last known to be in stable condition following the event.An x-ray was provided.The explanted devices are not available for return as the hospital does not allow it.No device images were provided.No further information.

• Brand Name: EQUINOXE CAGE GLENOID XL, POST AUG, RIGHT
• 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: 23407913
• Report Number: 1038671-2025-03226
• Device Sequence Number: 18408628
• Product Code: KWT
• UDI-Device Identifier: 10885862658043
• UDI-Public: 10885862658043
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/28/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 314-13-35
• 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: 10/09/2025
• Initial Report FDA Received Date: 10/28/2025
• 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 Age: 66 YR
• Patient Sex: Male