MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; LONG HUMERAL DIAPHYSIS - L200 - 12

Model Number	04.01.0230
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 oct 2025 lot 2409944: (b)(4) items manufactured and released on 17-jun-2024.Expiration date: 2029-jun-03.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 medical affairs department revision 3 months after the previous surgery due to humeral stem loosening.Bacteriological tests were negative.This was a second revision for this patient; the first one was done due to a periprosthetic fracture following a traumatic event.From the radiographic images, it is visible the long stem and a plate used in the previous revision used to stabilize the fractured humerus.The case is complex, the bone quality is compromised, it was in a challenging condition and failed to achieve integration.There is no indication of a device-related issue.Conclusions: aseptic loosening is a possible literature-described adverse event following shoulder arthroplasties and causes are often unknown.In this case, the loosening likely resulted from poor bone quality and complex anatomical conditions following previous trauma, which limited the potential for osseointegration and mechanical stability.There is no indication that any potential issue with the device may have caused or contributed to the event.
Event or Problem Description
The patient had primary surgery on (b)(6) 2020.On (b)(6) 2025, the patient underwent revision surgery due to a peri-prosthetic fracture with loosening of the baseplate following a fall.The surgeon revised the diaphysis, metaphysis and liner with new implants, while the baseplate and glenosphere were removed.No glenoid implants were placed at that time, as a custom glenoid implant was awaited.On (b)(6) 2025, the patient underwent revision surgery due to humeral stem loosening.Diaphysis, metaphysis and liner were revised and custom glenoid was implanted.Bacteriological tests were negative.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: LONG HUMERAL DIAPHYSIS - L200 - 12
• 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: 23356471
• Report Number: 3005180920-2025-01020
• Device Sequence Number: 8871093
• Product Code: KWS
• UDI-Device Identifier: 07630040734097
• UDI-Public: 07630040734097
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K192967
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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: 04.01.0230
• Device Lot Number: 2410177
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/22/2025
• 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 Sex: Male
• Patient Weight: 105 KG
• Patient Race: White