MAUDE Adverse Event Report: ARTHREX, INC. 33/24 GLENOSPHERE; SHOULDR PROSTH, REVERSE CONFIG

Model Number	33/24 GLENOSPHERE
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/16/2025
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
On 6/11/2025, a clindex notification was received indicating that a patient listed on the shoulder arthroplasty registry presented with increased shoulder pain on (b)(6) 2025.Radiographs revealed a dislocation.The patient required an urgent revision to rsa.The initial surgery, which included implantation of the univers revers apex, was performed on (b)(6) 2025.The event was indicated as probably related to the univers revers apex implant.Additional information received on 6/26/2025: an ar-9503xs-03 humeral insert and an ar-9564-2433 glenosphere were removed during the revision surgery on (b)(6) 2025.At the two-week postoperative visit on (b)(6) 2025, the patient was doing well and reported no pain.Radiographs at that time confirmed that the implant was in a stable position, with no signs of dislocation.
Additional Manufacturer Narrative
Additional information: b5, d6a, d6b, g3, h3, h6.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information was received via email on 8/8/2025: the facility representative indicated that the dislocation was initially noted to be "probably related" to arthrex products in error.It should have been noted as "not related.".
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event resulting in a revision surgery.

• Brand Name: 33/24 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 -194
• Manufacturer Contact: jared engle ; 8009337001-73216
• MDR Report Key: 22554663
• Report Number: 1220246-2025-02975
• Device Sequence Number: 9637881
• Product Code: PHX
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/29/2026

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: 33/24 GLENOSPHERE
• Device Catalogue Number: AR-9564-2433
• Device Lot Number: 24.02826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 08/08/2025; 10/26/2025; 09/22/2026
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/26/2025; 10/01/2025; 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown