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	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: 5789123, 300-01-11 - equinoxe, humeral stem primary, press fit 11mm; 5150165, 300-51-15 - 1.5 short fa rep plt kit; 5148477, 310-01-44 - equinoxe, humeral head short, 44mm (alpha); 5816704, 315-35-00 - glnd kwire; 5546691, 531-78-20 - shouldr gps hex pins kit.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 60 yo female, initial right shoulder implanted (b)(6) 2019, underwent a revision procedure on (b)(6) 2022, approximately 3 years 8 months post the initial procedure.Per the surgeon, "the glenoid failed" and occurred over time.The patient was last known to be in stable condition following the event.The product is not returning due to hospital policy.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: d1, h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The reason for the revision reported cannot be conclusively determined but may have been the result of prosthesis wear of the cage glenoid.The wear may have been due to metal-on-metal articulation between unintended components and wear of the glenoid body due to the fracture of the center cage and subsequent boring through the glenoid body.However, the reported and investigated failures and this underlying cause cannot be confirmed because the provided image does not clearly show the state of the revised glenoid, and no relevant clinical information or radiographs were provided.Potential contributions of patient or user-related considerations to the event cannot be determined from the reported information.Should additional relevant information be obtained, a follow-up mdr will be submitted 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: geoff gannon ; 3523771140
• MDR Report Key: 15789671
• Report Number: 1038671-2022-01458
• Device Sequence Number: 5578737
• Product Code: KWS
• UDI-Device Identifier: 10885862201003
• UDI-Public: 10885862201003
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: 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): 10/16/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/09/2022
• 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: 10/25/2022
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female