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

Catalog Number	314-13-23
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 5527605 300-01-15 - equinoxe, humeral stem primary, press fit 15mm.5485730 300-10-45 - equinoxe replicator plate 4.5mm o/s.5219514 300-20-02 - equinox square torque define screw drive kit.5340159 300-30-08 - equinoxe preserve stem 8mm.5380933 310-01-50 - equinoxe, humeral head short, 50mm (beta).4250631 314-13-23 - equinoxe cage glenoid m, post aug, left.5589758 531-78-20 - shoulder gps hex pins kit.07020018085 a10012 - gps implant kit v2.
Event or Problem Description
It was reported that this patient's shoulder was revised approximately 5 years 10 months post op.The revision was due to pain.Extensive bone grafting was done.No baseplate was implanted at this time.Surgeon wanted to let the bone graft heal as much as possible and then will complete the surgery in a few months.No issues with surgery today.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, d4, g4, h4, h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The reason for the revision reported was likely due to prothesis wear and fracture.However, the causes of the wear and fracture cannot be confirmed from the provided information but may include incomplete seating of the implant and/or improper glenoid preparation leading to a rocking horse effect and/or the inclusion of the polyethylene in the packaging recall.Potential user and patient-related contributions to the event could not be evaluated from the provided information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE CAGE GLENOID M, POST AUG, LEFT
• 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
• MDR Report Key: 20040922
• Report Number: 1038671-2024-03012
• Device Sequence Number: 7896794
• Product Code: KWS
• UDI-Device Identifier: 10885862196170
• UDI-Public: 10885862196170
• 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: 2018
• 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): 03/17/2025

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: 01/24/2021
• Device Catalogue Number: 314-13-23
• 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: 08/06/2024
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2016
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown