MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; HUMERAL REVERSE METAPHYSIS +0MM/0°

Model Number	04.01.0110
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Hematoma (1884); Aseptic loosening (4883)
Date of Event	10/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in due to developing a large hematoma.About 9 days after the primary surgery, the surgeon performed arthrotomy to treat the hematoma.Liner was revised because the hematoma was very deep into the joint.When removing the liner (with an osteotome), he tested the stability of the diaphysis (cementless).During this test, the stem came off easily.The surgeon finally revised glenosphere, liner, metaphysis and diaphysis (longer metaphysis implanted).
Additional Manufacturer Narrative
Batch review performed on 9 october 2025: reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot 2505417:(b)(4) manufactured and released on 20-jun-2025.Expiration date: 05-jun-2030.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.Additional implants involved, batch review performed on 9 october 2025: reverse shoulder system 04.01.0008 standard humeral diaphysis - cementless - 13 (k170452) lot 2101802: (b)(4) manufactured and released on 28-apr-2021.Expiration date: 15-apr-2026.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0126 humeral reverse hc liner ø42/+3mm (k170452) lot 2338159: (b)(4) manufactured and released on 02-jan-2024.Expiration date: 13-dec-2028.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0209 lat.Glenosphere 42xø24.5 (k170452) lot 2501162: (b)(4) manufactured and released on 19-feb-2025.Expiration date: 05-feb-2030.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.Conclusion: 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.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: HUMERAL REVERSE METAPHYSIS +0MM/0°
• 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: 23334288
• Report Number: 3005180920-2025-01032
• Device Sequence Number: 9937522
• Product Code: PHX
• UDI-Device Identifier: 07630040706179
• UDI-Public: 07630040706179
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• 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): 10/20/2025

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: 04.01.0110
• Device Lot Number: 2505417
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2025
• 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: 66 YR
• Patient Sex: Male
• Patient Race: White