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

Catalog Number	314-13-33
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 74 y/o male patient underwent a right total shoulder replacement approximately 4 years and 11 months post op.Patient had right shoulder osteoarthritis and biceps tendonitis.The patient was discharged home.The patient was doing well as of (b)(6) 2018.The patient contacted the surgeon to report that over the past year he experienced increasing pain and decreasing function of his right shoulder until the point where he has very little function of the right shoulder.He was worked up by a surgeon outside of hss and was diagnosed with glenoid failure, for which he was indicated for revision to reverse shoulder, provided there was no evidence of infection.Surgeon reviewed his x-rays (from facility outside of hss) that showed it appeared that he had loosening of the glenoid component.The patient underwent a revision/conversion of failed right total shoulder to reverse shoulder replacement with glenoid bone grafting and humeral osteotomy w/ cerclage repair at an outside facility.Intraoperatively, with dissection on the proximal humerus down to the level of the deltoid laterally, releasing subdeltoid adhesions " there is significant stiffness and already polyethylene wear could be noted proximally.Significant stiffness of the humeral head.Significant posterior thinning of the cortex.The glenoid was easily removed as it was loose.A femoral head allograft was fashioned to fit in the large posterior inferior quadrant defect.Fort the remaining defects a combination of dbx putty cancellous chips and trinity inductive bone graft were packed in place." the patient has not been back to hss.The device that is the subject of this report was included in the recall (following 16-jan-2024 safety notice) of exactech equinoxe reverse total shoulder arthroplasty and anatomic total shoulder arthroplasty uhmwpe humeral liners and glenoids that were packaged in non-conforming packaging.Device is not available for evaluation.Device was not serviced by 3rd party servicer.
Additional Manufacturer Narrative
(h3) pending evaluation.(d10) concomitant device(s): (b)(6) 300-10-45 - equinoxe replicator plate 4.5mm o/s; (b)(6) 300-20-02 - equinox square torque define screw drive kit; (b)(6) 300-30-06 - equinoxe preserve stem 6mm; (b)(6) 310-01-50 - equinoxe, humeral head short, 50mm (beta).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and glenoid loosening.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.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, RIGHT
• 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: 19611245
• Report Number: 1038671-2024-02122
• Device Sequence Number: 17886014
• Product Code: KWT
• UDI-Device Identifier: 10885862201010
• UDI-Public: 10885862201010
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 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
• Report Date (Section B): 02/10/2025

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: 09/06/2020
• Device Catalogue Number: 314-13-33
• 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: 06/05/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 02/10/2025
• Date Device Manufactured: 09/09/2015
• 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.
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White