MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; HUMERAL REVERSE HC LINER Ø42/+6MM

Model Number	04.01.0127
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 march 2026.Reverse shoulder system 04.01.0127 humeral reverse hc liner d 42/+6mm lot.2301886 lot 2301886 (k170452): (b)(4) items manufactured and released on 08 may 2023.Expiration date: 2028-apr-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Reverse shoulder system 04.01.0209 lat.Glenosphere 42xd 24.5 lot.2418603 lot 2418603 (k193175): (b)(4) items manufactured and released on 09 dec 2024.Expiration date: 2029-nov-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Root cause: 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
Revision surgery due to instability about 4 months after last revision surgery and the cause is unknown.No trauma was reported.The surgeon removed the sphere and checked the baseplate for looseness, but it was secure.The surgeon revised the glenosphere, metaphysis and liner.The surgery was completed successfully.The patient had primary on (b)(6) 2023.On (b)(6) 2025 first revision due to stiffness.On (b)(6) 2025 second revision surgery due to instability.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: HUMERAL REVERSE HC LINER Ø42/+6MM
• 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: 24738811
• Report Number: 3005180920-2026-00279
• Device Sequence Number: 21438039
• Product Code: PHX
• UDI-Device Identifier: 07630040706346
• UDI-Public: 07630040706346
• Combination Product (Y/N): N
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 03/31/2026

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: 04.01.0127
• Device Lot Number: 2301886
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2023
• 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: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: White