MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMIC SHOULDER PROSTHESIS; ANATOMICAL SHOULDER SYSTEM 04.01.0026 HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS

Model Number	04.01.0026
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	01/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 febr 2025.Lot 2307561: (b)(4) items manufactured and released on 12-oct-2023.Expiration date: 2028-09-19.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.Other devices involved: anatomical shoulder system 04.01.0089 double eccenter (k170910) lot 2345858: (b)(4) items manufactured and released on 23-feb-2024.Expiration date: 2029-02-11.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.Anatomical shoulder system 04.01.0092 metal humeral head ø44 (k170910) lot 2001820: (b)(4) items manufactured and released on 28-jul-2020.Expiration date: 2025-07-17.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.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
The patient had a primary shoulder surgery on (b)(6) 2024.On (b)(6) 2024, while in physical therapy, it was observed that the baseplate cut out posteriorly and the cause is unknown.The surgeon converted the patient from a reverse to a hemi.The surgery was completed successfully.On (b)(6) 2025, the patient has been reporting pain and lack of range of motion to the surgeon.The surgeon has requested a custom glenoid baseplate to alleviate the patient's pain.The patient will undergo a 2nd revision surgery.
Additional Manufacturer Narrative
Information added in this fu: - event description.- date of explantation.
Event or Problem Description
Updated decription of the event: the patient had a primary shoulder surgery on (b)(6) 2024.On (b)(6) 2024, while in physical therapy, it was observed that the baseplate cut out posteriorly and the cause is unknown.The surgeon converted the patient from a reverse to a hemi.The surgery was completed successfully.On (b)(6) 2025 , the patient has been reporting pain and lack of range of motion to the surgeon.The surgeon has requested a custom glenoid baseplate to alleviate the patient's pain.On (b)(6) 2025 , the patient underwent revision surgery.Custom reverse glenoid, liner and metaphysis were implanted.

• Brand Name: ANATOMIC SHOULDER PROSTHESIS
• Common Device Name: ANATOMICAL SHOULDER SYSTEM 04.01.0026 HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS
• 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: 21432768
• Report Number: 3005180920-2025-00124
• Device Sequence Number: 17297714
• Product Code: KWS
• UDI-Device Identifier: 07630040712644
• UDI-Public: 07630040712644
• 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: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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: 04.01.0026
• Device Lot Number: 2307561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2023
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Race: White