MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMIC SHOULDER PROSTHESIS; STANDARD HUMERAL DIAPHYSIS - CEMENTLESS, SIZE 9

Model Number	04.01.0004
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	08/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31 july 2025: lot 2000901: (b)(4) items manufactured and released on 08-june-2020.Expiration date: 28-may-2025.No anomalies were found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation: revision 4 years and 9 months after primary rsa due to proximal stem loosening.Radiographic evaluation shows radiolucent lines around the proximal part of the stem, gaps between the prosthesis and bone, and signs of osteolysis, all suggesting poor osseointegration.Subsidence of the stem within the humeral canal may also be present.These findings are consistent with proximal loosening, a known adverse event described in the literature following primary shoulder arthroplasty.In the absence of additional clinical or radiological history, we assume this is a case of aseptic loosening.Conclusion: 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
Revision surgery at about 4 years and 9 months from primary due to proximal stem loosening.The surgeon revised all components to competitor components, and the surgery was completed successfully.

• Brand Name: ANATOMIC SHOULDER PROSTHESIS
• Common Device Name: STANDARD HUMERAL DIAPHYSIS - CEMENTLESS, SIZE 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: 22892575
• Report Number: 3005180920-2025-00801
• Device Sequence Number: 8984680
• Product Code: KWS
• UDI-Device Identifier: 07630040706032
• UDI-Public: 07630040706032
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170910
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2025

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: 05/28/2025
• Device Model Number: 04.01.0004
• Device Lot Number: 2000901
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2020
• 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: Unknown