MAUDE Adverse Event Report: ARTHREX, INC. 42 +4 LAT/24 GLENOSPHERE; SHOULDR PROSTH, REVERSE CONFIG

Model Number	42 +4 LAT/24 GLENOSPHERE
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 10/28/2024, it was reported by a sales representative via email that an ar-9564-2442-lat glenosphere and glenosphere set screw disengaged from the baseplate.The patient underwent surgery on (b)(6) 2023 for a reverse shoulder arthroplasty.Postoperatively the patient experienced pain and a ct scan revealed glenosphere and glenosphere set screw disengaged from the baseplate.On 10/16/23 the patient underwent a revision surgery in which a new glenosphere along with humeral components were implanted.No further information was provided.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information received on 11/4/2024: during the revision surgery, the ar-9502f-39lcpc suturecup, the ar-9503-3942-3 humeral insert, the ar-9501-07p humeral stem, the ar-9582-20 modular post, the ar-9563-28 peripheral locking screw, the ar-9563-16 peripheral locking screw, the ar-9563-20 peripheral locking screw, the ar-9562-40nl peripheral locking screw, the ar-9580-2010-2s baseplate, and ar-9564-2442-lat glenosphere was removed.Both procedures were performed by the same surgeon and at the same facility.
Additional Manufacturer Narrative
Additional information: b5, g3.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, noted around the threads of the arthrex® univers revers¿ modular glenoid system gleno sphere 42 +4 lat / 24 had normal wear/warped where a screw was disengaged from the baseplate, and the base was scratched.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.D.Adverse effects.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.The most likely cause of the reported failure may be a patient-specific event, due to extreme stress or strain resulting from work or sport-related activity and the wear of the returned matting humeral insert since the implantation surgery.
Additional Manufacturer Narrative
Correction: b3.

• Brand Name: 42 +4 LAT/24 GLENOSPHERE
• 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: 20640183
• Report Number: 1220246-2024-08475
• Device Sequence Number: 20699094
• Product Code: PHX
• UDI-Device Identifier: 00888867295742
• UDI-Public: (01)00888867295742(11)230401(17)280331(10)22.04100
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/08/2025

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: 42 +4 LAT/24 GLENOSPHERE
• Device Catalogue Number: AR-9564-2442-LAT
• Device Lot Number: 22.04100
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 11/04/2024; 02/03/2025; Not provided
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 11/19/2024; 02/18/2025; 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• 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