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

Model Number	EQUINOXE CAGE GLENOID LARGE, BETA
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Muscle/Tendon Damage (4532); Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 9.3 years post initial right tsa, the male patient had a revision due to wear and osteolysis.A competitor¿s reverse glenoid was used with fresh femoral head bone grafting.The exactech stem was attempted to be kept but it was too tight, so it was then removed and converted to a competitor¿s stem broached lower into the humerus for space.No complications were noted.Explants not available.
Additional Manufacturer Narrative
Section d10: concomitant products equinoxe, humeral stem primary, press fit 11mm (cat# 300-01-11 / serial# (b)(4)), equinoxe replicator plate 4.5mm o/s (cat# 300-10-45 / serial# (b)(4)), equinox square torque define screw drive kit (cat# 300-20-02 / serial# (b)(4)), equinoxe, humeral head short, 47mm (beta) (cat# 310-01-47 / serial# (b)(4)), equinoxe reverse shoulder drill kit (cat# 321-20-00 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
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 reason for the revision reported cannot be confirmed from the information provided but may be the result of fracture, an insufficient bond between the glenoid component and the bone, which led to aseptic (non-infected) glenoid loosening, and/or the 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 relevant clinical information was not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE CAGE GLENOID LARGE, BETA
• 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16785896
• Report Number: 1038671-2023-00789
• Device Sequence Number: 5691542
• Product Code: KWT
• UDI-Device Identifier: 10885862172716
• UDI-Public: 10885862172716
• 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: 2014
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2018
• Device Model Number: EQUINOXE CAGE GLENOID LARGE, BETA
• Device Catalogue Number: 314-13-14
• 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: 03/30/2023
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2013
• 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: Male