MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER - TINBN COATING; SENSITIN LAT. GLENOSPHERE 36XØ24.5

Model Number	04.01.0278
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	08/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 sept 2025 reverse shoulder system 04.01.0278 sensitin lat.Glenosphere 36xø24.5 (k203755) lot.2305244: (b)(4) items manufactured and released on 21 june 2023.Expiration date: 07-june-2028.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 devices involved: reverse shoulder system 04.01.0120 humeral reverse hc liner ø36/+3mm (k170452) lot.2400593: (b)(4) items manufactured and released on 15 april 2024.Expiration date: 02-april-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.Conclusion: the surgeon revised the liner and glenosphere height, which is a common practice to restore joint stability.There is no indication that any potential issue with the device may have caused or contributed to the event.
Event or Problem Description
After 8 months from the primary surgery, the patient came in reporting instability, and the cause is unknown.The surgeon upsized the glenosphere and liner to give the patient more stability.The surgery was completed successfully.

• Brand Name: SHOULDER - TINBN COATING
• Common Device Name: SENSITIN LAT. GLENOSPHERE 36XØ24.5
• 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: 23070931
• Report Number: 3005180920-2025-00902
• Device Sequence Number: 10064594
• Product Code: KWS
• UDI-Device Identifier: 07630345709004
• UDI-Public: 07630345709004
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K203755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2025

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: 04.01.0278
• Device Lot Number: 2305244
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2023
• 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: 70 YR
• Patient Sex: Female