MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; GLENOSPHERE - Ø36X24.5

Model Number	04.01.0169
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Impingement (4834)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 mar 2026.Lot 179110: (b)(4) items manufactured and released on 28-mar-2018.Expiration date: 2030-mar-14.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by r&d project manager based on the information provided, the patient presented with pain due to impingement associated with scapular notching.The surgeon revised the original glenosphere to a lateralized glenosphere with the aim of reducing impingement.Given the limited image quality, it is not possible to draw conclusions beyond what is already described in the report.However, a suboptimal positioning of both the baseplate and the glenosphere may have contributed to the impingement and subsequent scapular notching.Root cause:based on the information available no definitive root cause can be established, however, a suboptimal positioning of both the baseplate and the glenosphere may have contributed to the impingement and subsequent scapular notching.There is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
At6 years 5 months from primary, the patient came in presenting pain due to impingement caused by scapula notching.The surgeon revised the glenosphere - d 36x24.5 to a lat.Glenosphere 42xd 24.5 to reduce impingement.The surgery was completed successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: GLENOSPHERE - Ø36X24.5
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 24762671
• Report Number: 3005180920-2026-00257
• Device Sequence Number: 13331210
• Product Code: PHX
• UDI-Device Identifier: 07630040706568
• UDI-Public: 07630040706568
• Combination Product (Y/N): N
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

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 Expiration Date: 03/14/2023
• Device Model Number: 04.01.0169
• Device Lot Number: 179110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2018
• 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: Required Intervention
• Patient Sex: Female