MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE CAGE SCREW L, 40MM; TOT ANAT SHOULDR PROSTH, UNCEM

Model Number	ECLIPSE CAGE SCREW L, 40MM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that on pictures it was found that after an implantation in (b)(6) 2007 the coating of the pan is abraded and a metallosis is suspected.No information provided by the customer.***update dw 01-aug-2024: further information was provided that the prosthesis was implanted in agatharied from (b)(6) in (b)(6) 2007.3 years ago, the prosthesis started to making noises in specific movements.(b)(6) has diagnosed a wear of the poly with a metallosis and osteolysen.The surgeon advised the patient to clarify the event with an additional arthroscopy.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint is confirmed based on the x-ray ((b)(4)) provided by the customer, which shows the humeral head making direct contact with the baseplate, with no polyethylene base in between.The constant rubbing of both metals can contribute to metallosis.The absence of the polyethylene base may be a consequence of device wear due to an active lifestyle.Considering the implantation surgery was in (b)(6) 2007, and the reported event occurred on (b)(6) 2024, this wear is understandable after 17 years.The directions for use (dfu) for eclipse shoulder prothesis, section c.Contraindications.1.Insufficient quantities or quality of humeral head and/or humeral neck bone stock.5.Metal allergy.D.Adverse effects.2.Allergies and other reactions to device materials.3.Loosening of the implant as a result of changed conditions in load transfer, respectively, fatigue wear, or tissue reaction to the implant.Loosening is frequently a consequence of one or several of the above listed risk conditions but can also be caused by inadequate anchoring technique.E.Warnings.17.An artificial joint is subject to wear and/or can loosen over a period of time.Wear and loosening may make it necessary to re-operate on an artificial joint.H.Factors and risks impacting the safety and service life of the implant.1.Patient weight.An overweight patient may present additional risk.2.Extreme stress or strain resulting from work or sport-related activity.6.Deformation of the operative site, which can prevent or impede anchoring of the implant.8.Allergic reactions to implant materials.Based on the information provided, the most likely cause of the reported failure may be a patient-specific event, specifically the wear of the polyethylene base due to an active lifestyle and/or the passage of 17 years since the implantation surgery.

• Brand Name: ECLIPSE CAGE SCREW L, 40MM
• Common Device Name: TOT ANAT SHOULDR PROSTH, UNCEM
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19966876
• Report Number: 1220246-2024-07155
• Device Sequence Number: 8962128
• Product Code: QHQ
• UDI-Device Identifier: 00888867059948
• UDI-Public: 00888867059948
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K183194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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: 03/31/2012
• Device Model Number: ECLIPSE CAGE SCREW L, 40MM
• Device Catalogue Number: AR-9301-03
• Device Lot Number: 0717003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown