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

Model Number	EQUINOXE CAGE GLENOID M, POST AUG, RIGHT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately five years post initial right tsa, the female patient had a failure of anatomic shoulder replacement.Patient had a revision of legacy caged glenoid, the central cage appeared to have disassociated from the poly.There were no fragments, parts or pieces that fell into the patient wound site.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.Sales rep was unable to obtain x-rays.The device is not available for evaluation due to lost after case.
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 the revision reported was likely the result of prosthesis fracture of the glenoid.The cause of the fracture may be due to incomplete seating of the implant and/or off-axis drilling of the peripheral peg holes during implantation resulting in a rocking horse effect.However, the series of events could not be confirmed as the device was not returned for evaluation and no radiographs were 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, SEMI-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
• MDR Report Key: 19169322
• Report Number: 1038671-2024-00957
• Device Sequence Number: 7304134
• Product Code: KWS
• UDI-Device Identifier: 10885862201010
• UDI-Public: 10885862201010
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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 Expiration Date: 08/30/2023
• Device Model Number: EQUINOXE CAGE GLENOID M, POST AUG, RIGHT
• Device Catalogue Number: 314-13-33
• 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: 03/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2018
• 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: EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT.; EQUINOXE CAGE GLENOID M, POST AUG, RIGHT.; EQUINOXE REPLICATOR PLATE 1.5MM O/S.; EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA).; EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT.; GPS IMPLANT KIT V2.; GPS PER CASE RENTAL FEE56.; SHOULDR GPS HEX PINS KIT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female