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

Catalog Number	314-13-24
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): (b)(6) 300-10-15 - equinoxe replicator plate 1.5mm o/s.(b)(6) 300-20-02 - equinox square torque define screw drive kit.(b)(6) 300-30-08 - equinoxe preserve stem 8mm.(b)(6) 310-01-47 - equinoxe, humeral head short, 47mm (beta).(b)(6) 315-35-00 - glnd kwire.(b)(6) 531-78-20 - shouldr gps hex pins kit.
Event or Problem Description
It was reported that this 61 y/o male patient was revised approximately 3 years 3 months post op.Patient complained of pain.Poly sheered off from the pegs.Patient was last known to be in stable condition following the event.Product not returning: chain of command due to recall hospital will not release.
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, g.The revision reported may have been the result of pain and glenoid disassembly as reported.However, it remains unclear whether the peripheral peg and center cage disassembly occurred prior to or during removal as the metal pegs of the cages glenoid are designed to disassociate from the polyethylene during removal.Potential contributions of user or 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.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE CAGE GLENOID L, 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20177415
• Report Number: 1038671-2024-03393
• Device Sequence Number: 8931172
• Product Code: KWT
• UDI-Device Identifier: 10885862200983
• UDI-Public: 10885862200983
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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): 10/14/2025

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: 11/23/2025
• Device Catalogue Number: 314-13-24
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2020
• 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: 61 YR
• Patient Sex: Male