MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; LAT. GLENOSPHERE 39XØ24.5

Model Number	04.01.0208
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary shoulder surgery on (b)(6) 2025.On (b)(6) 2025, the patient came in reporting pain due to a dislocation of the liner from the glenosphere and the cause is unknown.The surgeon revised the liner.The surgery was completed successfully.(b)(4) was sent.Subsequently, on (b)(6) 2025, the patient came in reporting pain due to a dislocation of the liner from the metaphysis.The surgeon upsized the liner and (b)(4) was sent.Presently, the patient came in reporting pain due to a dislocation of the liner from the glenosphere.The surgeon revised the metaphysis, liner, glenosphere, screws, and baseplate.The patient was converted from a reverse shoulder to a hemi shoulder.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2025.Reverse shoulder system 04.01.0208 lat.Glenosphere 39xø24.5 (k193175) lot.2404990: (b)(4) items manufactured and released on 17-06-2024 expiration date: 2029-05-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.The similar event was on the same device; patient underwent revision surgery for dilocation but just the liner was revised additional component involved in the event: -reverse shoulder system 04.01.0124 humeral reverse hc liner ø39/+6mm (k170452) lot.2318840: (b)(4) items manufactured and released on 22-11-2023 expiration date: 2028-11-06.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.Clinical evaluation performed by clinical affairs department after 2 revisions for dislocation, the same happened on the third revision, therefore the surgeon decided to change the implant into a hemi.These events are normally originated by progression of disease to the soft tissues or insufficient re-establishment of soft tissue tension after the operation.No further conclusion can be drawn with the elements at hand.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.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: LAT. GLENOSPHERE 39XØ24.5
• 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: 22518250
• Report Number: 3005180920-2025-00647
• Device Sequence Number: 15473584
• Product Code: HSD
• UDI-Device Identifier: 07630040728072
• UDI-Public: 07630040728072
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2025

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: 04.01.0208
• Device Lot Number: 2404990
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2024
• 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 Age: 66 YR
• Patient Sex: Male