MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMIC SHOULDER PROSTHESIS; METAL HUMERAL HEAD Ø42

Model Number	04.01.0091
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 february 2026.Anatomical shoulder system 04.01.0091 metal humeral head d 42 (k170910) lot 1710022: (b)(4) items manufactured and released on 23-apr-2018.Expiration date: 15-apr-2023.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.Anatomical shoulder system 04.01.0129 hc pegged glenoid d 42 (k170910) lot 1907769: (b)(4) items manufactured and released on 04-dec-2019.Expiration date: 18-nov-2024.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.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.The surgeon revised an anatomical shoulder system to a reverse total system, 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
At about 3 years and 9 months from the primary, the patient came in presenting left shoulder pain and instability and the cause is unknown.No trauma was indicated as a contributing factor.The surgeon revised the shoulder from anatomical to a reverse shoulder system.No x-rays are available.The surgery was completed successfully.

• Brand Name: ANATOMIC SHOULDER PROSTHESIS
• Common Device Name: METAL HUMERAL HEAD Ø42
• 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: 24494910
• Report Number: 3005180920-2026-00199
• Device Sequence Number: 14725460
• Product Code: KWS
• UDI-Device Identifier: 07630040713146
• UDI-Public: 07630040713146
• Combination Product (Y/N): N
• PMA/510(K) Number: K170910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 03/03/2026

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 Expiration Date: 04/15/2023
• Device Model Number: 04.01.0091
• Device Lot Number: 1710022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2018
• 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 Sex: Male
• Patient Race: White