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

Model Number	EQUINOXE CAGE GLENOID S, POST AUG, LEFT
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products; equinoxe replicator plate 1.5mm o/s (cat# 300-10-15 / serial#: (b)(4)), equinox square torque define screw drive kit (cat# 300-20-02 / serial#: (b)(4)), equinoxe, humeral head tall, 44mm (alpha) (cat# 310-02-44 / serial#: (b)(4)), equinoxe humeral stem primary press fit 12mm (cat# 300-01-12 / serial#: (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 2.2 years post initial left side tsa, the 51 y/o female patient presented back to surgeon's office with complaints of their left primary shoulder pain.The patient underwent glenoid revision surgery due to glenoid failure.During the surgery, the humeral head and replicator implant were removed from the platform stem.The glenoid was examined and showed to be deformed and missing some poly portion posteriorly on the implant.The surgeon removed the cage glenoid implant and re-implanted a new equinoxe cage glenoid implant.A new replicator plate, screw kit, and humeral head were replaced on the primary platform stem also.The patient was closed and left the operation room (or) stable.All fragments, parts or pieces were removed.Patient was last known to be in stable condition following the event.Photos received.Sales rep was unable to obtain x-rays.The device is not available for evaluation as the devices were discarded.No other patient information/medical history reported.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported was likely the result of prosthesis wear secondary to shoulder instability.However, the extent and root cause of the prosthesis wear cannot be determined as the devices were not returned for evaluation and radiographs were unable to be obtained.The most probable root cause associated with the reported event of ¿prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.

• Brand Name: EQUINOXE CAGE GLENOID S, POST AUG, LEFT
• 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: 16495583
• Report Number: 1038671-2023-00381
• Device Sequence Number: 15031695
• Product Code: KWT
• UDI-Device Identifier: 10885862196163
• UDI-Public: 10885862196163
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 06/03/2026

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: 04/16/2022
• Device Model Number: EQUINOXE CAGE GLENOID S, POST AUG, LEFT
• Device Catalogue Number: 314-13-22
• 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: 02/19/2023
• Supplement Date Received by Manufacturer: 07/24/2023; 05/13/2026
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 08/22/2023; 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2017
• 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: 51 YR
• Patient Sex: Female