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

Model Number	EQUINOXE CAGE GLENOID S, POST AUG, RIGHT
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Implant Pain (4561)
Date of Event	09/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: 300-10-45 - equinoxe replicator plate 4.5mm o/s.(b)(4).300-20-02 - equinox square torque define screw drive kit.(b)(4).300-30-06 - equinoxe preserve stem 6mm.(b)(4).310-02-44 - equinoxe, humeral head tall, 44mm (alpha) (b)(4).321-20-00 - equinoxe reverse shoulder drill kit.(b)(4).531-78-20 - shoulder gps hex pins kit (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported a female patient, initial right shoulder implanted on (b)(6) 2018, underwent a revision procedure on (b)(6) 2022, approximately 3 years 9 months post the initial procedure.The patient complained of pain.The surgeon findings indicated wear on glenoid.Patient last known to be in stable condition.The explants are not available for return.No other information available.
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: a, b, c, d, e, g.The revision reported was likely the result of prosthesis wear and fracture.An additional reason for the reported revision may be inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation.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 S, 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: kate jacobson ; 3523771140
• MDR Report Key: 15675281
• Report Number: 1038671-2022-01354
• Device Sequence Number: 17753185
• Product Code: KWS
• UDI-Device Identifier: 10885862201003
• UDI-Public: 10885862201003
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2022
• 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): 03/28/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/30/2021
• Device Model Number: EQUINOXE CAGE GLENOID S, POST AUG, RIGHT
• Device Catalogue Number: 314-13-32
• 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: 09/30/2022
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 03/28/2025
• Date Device Manufactured: 02/01/2016
• 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 Sex: Female