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

Catalog Number	314-13-33
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): (b)(6), 300-10-45 - equinoxe replicator plate 4.5mm o/s.(b)(6), 300-20-02 - equinox square torque define screw drive kit.(b)(6), 300-30-08 - equinoxe preserve stem 8mm.(b)(6), 310-01-47 - equinoxe, humeral head short, 47mm (beta).(b)(6), 314-13-33 - equinoxe cage glenoid m, post aug, right.
Event or Problem Description
It was reported that a 78 yo male patient, initial right shoulder implanted on (b)(6) 2019, underwent a revision procedure on (b)(6) 2024, approximately 4 years 3 months post the initial procedure.The patient had progressive deterioration of their implant.The surgeon elected to remove the implants due to implant failure which were worn over time while in situ.The patient was revised to exactech devices.During the procedure, the surgeon was able to retain the existing stem and he revised the glenoid to a reverse construct.All pieces of the implant which were worn and fragmented were removed from the patient.There were no surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were provided.The explanted devices are available for return, device images were provided.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, e, g.The revision reported was likely the result of prosthesis wear and fracture of the caged glenoid component.The cause of glenoid wear and fracture cannot be conclusively determined but may be related to improper device orientation during implantation resulting in abnormal and/or unintended forces.Potential contributions of user or patient-related considerations to the event could not be assessed from the information provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE CAGE GLENOID M, 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19153924
• Report Number: 1038671-2024-00923
• Device Sequence Number: 7960720
• Product Code: KWT
• UDI-Device Identifier: 10885862201010
• UDI-Public: 10885862201010
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: 08/25/2024
• Device Catalogue Number: 314-13-33
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1415-2024
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 76 KG