MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 42MM GLENOSPHERE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-01-42
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	04/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant devices: 320-42-03 - equinoxe rev 42mm humeral liner +2.5: 2860533, 320-10-00 - equinoxe rev adapter plate tray +0: 4272963, 320-15-05 - eq rev locking screw: 4257789, 320-20-00 - eq reve torque defining screw kit: 4270702.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent an initial total shoulder replacement on the left side.Subsequently, the patient experienced deterioration of the poly over the last year.Patient's x-ray a year ago looked good, but as of recent, the x-ray shows the humeral tray right up against the glenosphere.The surgeon said that the patient suffered a fall.As a result, approximately 8 years after initial replacement, the patient underwent a left shoulder revision.In surgery, once down to the implants, a lot of the tissue was blackened and the liner looked in very bad shape as well as the glenosphere.Patient liner looked very worn down and there were obvious signs of metallosis due to the condition of the glenosphere, liner, tray and all of the black tissue.No further impact to the patient was reported.No other information is available.As of note: "there was no signs of infection after taking cultures.Going into the case, the surgeon thought patients fall may have cracked the liner which caused the metal tray to start articulating on the glenosphere.Liner did not appear to be cracked but was damaged from the abnormal wear".
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear, secondary to disassembly of the humeral liner from the humeral tray.This likely resulted in articulation between the glenosphere and the humeral tray, resulting in the reported metallosis.Prosthesis wear could be confirmed on the humeral liner and the glenosphere; however, wear of the humeral tray could not be confirmed from the provided information additional reasons for the reported revision may be inclusion of the polyethylene in the packaging recall.Potential contributions of user and additional patient-related considerations to the event could not be assessed as the devices were not available for evaluation.H6: corrected investigation clinical codes.

• Brand Name: EQUINOXE REVERSE 42MM GLENOSPHERE
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21635465
• Report Number: 1038671-2025-01606
• Device Sequence Number: 18460728
• Product Code: KWT
• UDI-Device Identifier: 10885862086396
• UDI-Public: 10885862086396
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/27/2025
• Device Catalogue Number: 320-01-42
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 03/25/2025
• Date Device Manufactured: 04/29/2015
• 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.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male