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	Crack (1135); Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 300-01-13 - equinoxe, humeral stem primary, press fit 13mm; (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), 310-01-44 - equinoxe, humeral head short, 44mm (alpha); (b)(6), 315-35-00 - glnd kwire.
Event or Problem Description
It was reported that a 72 yo female patient, initial left shoulder implanted in (b)(6) 2018, underwent a revision procedure in (b)(6) 2024, approximately 6 years 11 months post the initial procedure.The surgeon converted the left tsa to a rsa.Extreme pitting on the backside of the implant was indicated.There were no device breakages or surgical delays during the procedure.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 available for return.No device images were able to be obtained.No further information.
Additional Manufacturer Narrative
D1: corrected.H6: corrected medical device, component, and investigation clinical codes.

• 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 21029583
• Report Number: 1038671-2024-05033
• Device Sequence Number: 14483084
• Product Code: KWT
• UDI-Device Identifier: 10885862172686
• UDI-Public: 10885862172686
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: 03/22/2022
• Device Catalogue Number: 314-13-03
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2017
• 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: 72 YR
• Patient Sex: Female