MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMIC SHOULDER PROSTHESIS; ANATOMICAL SHOULDER SYSTEM 04.01.0096 METAL HUMERAL HEAD Ø52

Model Number	04.01.0096
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	12/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year and 11 months from primary, the patient came in reporting pain and the surgeon observed the humeral head disassociating from the double center and the cause is unknown.The surgeon revised the head and double decenter.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 19-12-2024 lot 2003783: (b)(4) items manufactured and released on 21-10-2020.Expiration date: 2025-10-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.Other device involved: anatomical shoulder system 04.01.0089 double decenter (k170910) lot 2114001: (b)(4) items manufactured and released on 05-01-2022.Expiration date: 2026-12-09.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.

• Brand Name: ANATOMIC SHOULDER PROSTHESIS
• Common Device Name: ANATOMICAL SHOULDER SYSTEM 04.01.0096 METAL HUMERAL HEAD Ø52
• 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: 21183999
• Report Number: 3005180920-2024-01164
• Device Sequence Number: 8537713
• Product Code: KWS
• UDI-Device Identifier: 07630040713191
• UDI-Public: 07630040713191
• 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: 2023
• Device Explanted Year: 2024
• 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): 01/17/2025

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: 10/08/2025
• Device Model Number: 04.01.0096
• Device Lot Number: 2003783
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2020
• 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 Age: 60 YR
• Patient Sex: Male