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

Catalog Number	314-13-32
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this female patient's right shoulder was revised 5 years 10 months post op initial surgery.Surgeon voiced his concerns about the glenoid to (b)(6) after a anatomic to reverse revision surgery and after he found out about a recall.Glenoid was revised to competitors device.Patient was last known to be in stable condition following the event.Devices are not returning, hospital kept.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation: (d10) concomitant device(s): ab0646 - 13a2101 - cemex system fast genta 70g, ab0991 - 13a2111 - cemex system fast genta 40g, 1896962 - 300-01-07 - equinoxe, humeral stem primary, press fit 7mm, 5093274 - 300-01-09 - equinoxe, humeral stem primary, press fit 9mm, 5128477 300-20-02 - equinox square torque define screw drive kit, 5182909 - 300-20-02 - equinox square torque define screw drive kit, 5151345 - 300-50-45 - 4.5mm short rep plate, 5028015 - 310-01-47 - equinoxe, humeral head short, 47mm (beta), 4250976 - 314-13-32 - equinoxe cage glenoid s, post aug, right, 8012017045 - a10012 - gps implant kit v2, ab0898r - cnl-09 - small cement cannula.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d2a, d2b, g1, h6.The reason for the revision reported cannot be confirmed from the information provided but may be due to inclusion of the polyethylene in the packaging recall wear, loosening, infection, fracture, instability, dislocation, rotator cuff tear, and/or patient related factors.Potential contributions of manufacturing, user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and relevant clinical information was not provided.The radiograph provided appears unremarkable.H6: corrected health effect, medical device, component, and investigation clinical codes.
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.The reason for the revision reported cannot be confirmed from the information provided but may be due to inclusion of the polyethylene in the packaging recall wear, loosening, infection, fracture, instability, dislocation, rotator cuff tear, and/or patient related factors.Potential contributions of manufacturing, user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and relevant clinical information was not provided.The radiograph provided appears unremarkable.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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19203914
• Report Number: 1038671-2024-01005
• Device Sequence Number: 20814941
• Product Code: KWS
• UDI-Device Identifier: 10885862201003
• UDI-Public: 10885862201003
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2025

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: 01/24/2021
• 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: 04/09/2024
• Supplement Date Received by Manufacturer: 08/11/2025; 10/30/2025
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 08/27/2025; 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female