MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 9

Model Number	04.01.0182
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	07/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 august 2025.Lot 1903922: (b)(4) items manufactured and released on 10 july 2019.Expiration date: 2-june-2024.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: revision 5 years and 4 months after the primary rsa due to a loose stem.The bone quality of the humerus appears very low but we cannot establish the cause for this condition.No reason to suspect a faulty device 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
At approximately 5 years and 4 months after the primary surgery, the patient presented with pain due to a loose stem, the cause of which is unknown.The surgeon revised the medacta stem and liner with components from a competitor.The surgery was completed successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 9
• 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: 22949799
• Report Number: 3005180920-2025-00795
• Device Sequence Number: 21211092
• Product Code: KWS
• UDI-Device Identifier: 07630040715904
• UDI-Public: 07630040715904
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 09/03/2025

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 Expiration Date: 06/02/2024
• Device Model Number: 04.01.0182
• Device Lot Number: 1903922
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2019
• 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: 69 YR
• Patient Sex: Female