MAUDE Adverse Event Report: ARTHREX, INC. UNI GLENOID-PERIPHERAL LOCK SCRW; SHOULDR PROSTH, REVERSE CONFIG

Model Number	UNI GLENOID-PERIPHERAL LOCK SCRW
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	07/10/2024
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 a revision surgery was necessary due to a metallosis.The implant was implanted four years ago with bone graft augmentation.No further information was provided.Update dw 12-jul-2024: further information were provided that during an initial surgery on (b)(6) 2020 the following devices were implanted due to an omarthrosis with b2 glenoid situation with a retro of just under 30 degrees.Ar-9120-03, ar-9165-25nl, ar-9145-36, ar-9121-03, ar-9300-45cpc, ar-9301-04.On (b)(6) 2024 the revision surgery was performed.As part of the revision the eclipse and universal glenoid were all removed due to a severe metallosis.The surgeon decided to first build up the glenoid with allograft in a two-sided procedure and to insert a cement spacer on the humerus side.In the second step - a univers reverse will be inserted in autumn with planning.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint is confirmed based on the photograph provided by the customer, which shows the polyethylene base broken in half.The metallosis observed may be a consequence of the device breaking due to an active lifestyle and physical work, and the possibility that the metal was making contact due to the absence of the polyethylene base in between.Considering the implantation surgery was in (b)(6) 2020, and the reported event occurred on (b)(6) 2024, this wear is understandable after 4 years of an active lifestyle and physical work.The directions for use (dfu) for eclipse shoulder prosthesis, 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 (see below).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 break of the polyethylene base due to an active lifestyle and/or physical work and the passage of 4 years since the implantation surgery.

• Brand Name: UNI GLENOID-PERIPHERAL LOCK SCRW
• Common Device Name: SHOULDR PROSTH, REVERSE CONFIG
• 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: 19837700
• Report Number: 1220246-2024-06929
• Device Sequence Number: 6598203
• Product Code: PHX
• UDI-Device Identifier: 00888867057739
• UDI-Public: 00888867057739
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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 Model Number: UNI GLENOID-PERIPHERAL LOCK SCRW
• Device Catalogue Number: AR-9145-36
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 02/20/2025
• 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