MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM

Model Number	04.01.0124
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At 4 months from the primary, the patient came in reporting pain due to a dislocation of the liner from the glenosphere.The surgeon revised the liner and metaphysis.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 28 may 2025: lot 2103929: (b)(4) items manufactured and released on 28-may-2021.Expiration date: 2026-05-11.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.Reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot 2313410: (b)(4) items manufactured and released on 24-aug-2023.Expiration date: 2028-07-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 2 similar reported events during the period of review.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.
Additional Manufacturer Narrative
Among the additional involved devices in the initial report the following device and the related batch review were not reported due to human oversight reverse shoulder system 04.01.0208 lat.Glenosphere 39xø24.5 (k193175) lot.2243585 batch review performed on 12 jun 2025 (b)(4) items manufactured and released on 16-dec-2022.Expiration date: 2027-11-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with three similar reported events during the period of review, with no correlation established.Edited fields h11.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM
• 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: 22175047
• Report Number: 3005180920-2025-00554
• Device Sequence Number: 20822718
• Product Code: PHX
• UDI-Device Identifier: 07630040706315
• UDI-Public: 07630040706315
• 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: 2025
• 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): 06/27/2025

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 Expiration Date: 05/11/2026
• Device Model Number: 04.01.0124
• Device Lot Number: 2103929
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2021
• 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 Age: 83 YR
• Patient Sex: Female
• Patient Weight: 125 KG
• Patient Race: White