MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; GLENOSPHERE - Ø39X24.5

Model Number	04.01.0170
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 july 2025.Reverse shoulder system 04.01.0170 glenosphere - ø39x24.5 (k170452) lot 2409250: (b)(4) items manufactured and released on 02/09/2024.Expiration date: 24/07/2029.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional revised implants: reverse shoulder system 04.01.0124 humeral reverse hc liner ø39/+6mm (k170452) lot 2400595: (b)(4) items manufactured and released on 19/04/2024.Expiration date: 07/04/2029.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Conclusions: based on the information available no definitive root cause can be established, while 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
The patient came in reporting instability and the cause is unknown.About 7 months after the primary surgery, the surgeon revised the humeral reverse liner, reverse metaphysis and lateral glenosphere.He decided to increase the glenosphere size, the offset of the metaphysis, and the liner size to improve the stability.
Event or Problem Description
Additional info: the patient had primary on (b)(6) 2024.The first revision was on (b)(6) 2024, which would be complaint number (b)(4).The patient had a spacer implanted on that day.Then the patient came back and had a medacta spacer removed (date unknown) and a competitor spacer put in.So, (b)(4) is the first revision.So, on (b)(6) 2025, it was the revision of a competitor spacer.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: GLENOSPHERE - Ø39X24.5
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 22726919
• Report Number: 3005180920-2025-00762
• Device Sequence Number: 18230765
• Product Code: PHX
• UDI-Device Identifier: 07630040706575
• UDI-Public: 07630040706575
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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: 04.01.0170
• Device Lot Number: 2409250
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2024
• 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: Male