MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID MEDIUM, ALPHA; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-13-03
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	03/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the 71 year old female patient had an initial right tsa on (b)(6) 2019.The patient was revised on (b)(6) 2024 due to a failed glenoid.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): 531-78-20 - shouldr gps hex pins kit 6265431.A10012 - gps implant kit v2 10000219262.300-01-09 - equinoxe, humeral stem primary, press fit 9mm 6119646.300-20-02 - equinox square torque define screw drive kit 6104214.300-50-15 - 1.5mm short rep plate 5293116.310-00-47 - xs humeral head, 47mm xs offset humeral head 5289479.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: g1, g3, h6, h11 mdr section codes updated/corrected: a, b, c, d, e, g the revision reported was likely the result of prosthesis fracture of the center cage leading to fracture, wear, and disassembly of the glenoid component.The cause of the center cage fracture cannot be confirmed but may be due to improper initial seating of the glenoid and/or due to off-axis drilling of the peripheral pegs resulting in the rocking horse phenomenon.However, the cause and series of events cannot be confirmed as the devices were not returned for evaluation, and initial post-operative radiographs were not 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 MEDIUM, ALPHA
• 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 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19177881
• Report Number: 1038671-2024-00972
• Device Sequence Number: 17889757
• Product Code: KWT
• UDI-Device Identifier: 10885862172686
• UDI-Public: 10885862172686
• 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,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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2023
• Device Catalogue Number: 314-13-03
• 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: 04/01/2024
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female