MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMIC SHOULDER PROSTHESIS; STANDARD HUMERAL DIAPHYSIS - CEMENTLESS, SIZE 11

Model Number	04.01.0006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	08/15/2025
Type of Reportable Event	Death
Event or Problem Description
Primary surgery was performed on (b)(6) 2025 (b)(6) medical center.On (b)(6) 2025 revision surgery performed.The patient came in reporting pain after falling and landing on the shoulder, leading to a dislocation of the liner from the glenosphere.The surgeon revised only the liner (0 mm to 6 mm).Sometime in mid-(b)(6) 2025, the patient passed away due to heart failure.No issue with medacta devices.
Additional Manufacturer Narrative
Batch review performed on 25 august 2025: reverse shoulder system 04.01.0006 std humeral diaphysis - cementless - 11 (k170910) lot 2409955: (b)(4) items manufactured and released on 14-june-2024.Expiration date: 2029-05-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Additional implants involved, batch review performed on 25 august 2025: reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot 2414237: (b)(4) items manufactured and released on 13-sep-2024.Expiration date: 2029-09-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Reverse shoulder system 04.01.0161 glenoid polyaxial locking screw - l30 (k170452) lot 2417516: (b)(4) items manufactured and released on 19-july-2024.Expiration date: 2029-07-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Reverse shoulder system 04.01.0163 glenoid polyaxial locking screw - l38 (k170452) lot 2421551: (b)(4) items manufactured and released on 13-sep-2024.Expiration date: 2029-08-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Reverse shoulder system 04.01.0164 glenoid polyaxial locking screw - l42 (k170452) lot 2337218: (b)(4) items manufactured and released on 29-nov-2023.Expiration date: 2028-11-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Reverse shoulder system 04.01.0127 humeral reverse hc liner ø42/+6mm (k170452) lot 2307538: (b)(4) items manufactured and released on 08-aug-2023.Expiration date: 2028-07-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Reverse shoulder system 04.01.0174 glenosphere - ø42x27 (k170452) lot 1910956: (b)(4) items manufactured and released on 25-may-2020.Expiration date: 2025-05-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.My shoulder 04.01.Cm24.298 reconstruction reverse glenoid lot 19311p: (b)(4) items manufactured and released on 17-dec-2024.No anomalies found related to the problem.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.

• Brand Name: ANATOMIC SHOULDER PROSTHESIS
• Common Device Name: STANDARD HUMERAL DIAPHYSIS - CEMENTLESS, SIZE 11
• 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: 23001781
• Report Number: 3005180920-2025-00876
• Device Sequence Number: 8806770
• Product Code: KWS
• UDI-Device Identifier: 07630040706056
• UDI-Public: 07630040706056
• 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: 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): 09/09/2025

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: 04.01.0006
• Device Lot Number: 2409955
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2024
• 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: Death
• Patient Age: 76 YR
• Patient Sex: Male