MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; HUMERAL REVERSE HC LINER Ø32/+6MM

Model Number	04.01.0118
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 december 2025.Reverse shoulder system 04.01.0118 humeral reverse hc liner d 32/+6mm (k170452) lot 2303288: (b)(4) items manufactured and released on 04-july-2023.Expiration date: 2028-06-19.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 04.01.0206 lat.Glenosphere 32xd 24.5 (k193175) lot 2430417: (b)(4) items manufactured and released on 04-apr-2025.Expiration date: 2030-03-17.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: although a precise root cause cannot be established, these events are generally related to insufficient re-establishment of soft tissue tension after surgery.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 manufacturing-related issue.
Event or Problem Description
At about 3 months after the primary, the patient came in from pain associated with a dislocation and the cause is unknown.The surgeon revised the liner with a constrained liner of the same size to address the dislocations.The surgery was completed successfully.
Event or Problem Description
At about 3 months after the primary, the patient came in from pain associated with a dislocation and the cause is unknown.The surgeon revised the liner with a constrained liner of the same size to address the dislocations.The surgery was completed successfully.
Additional Manufacturer Narrative
On 17 february 2026 medacta us informed us about the correct information: date of the event: (b)(6) 2025.Correct event description: at about 3 months after the primary, the patient came in from pain associated with a dislocation and the cause is unknown.The surgeon revised the liner with a constrained liner of the same size to address the dislocations.The surgery was completed successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: HUMERAL REVERSE HC LINER Ø32/+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: 23858463
• Report Number: 3005180920-2025-01262
• Device Sequence Number: 10374153
• Product Code: PHX
• UDI-Device Identifier: 07630040706254
• UDI-Public: 07630040706254
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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: 04.01.0118
• Device Lot Number: 2303288
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2023
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: White