MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; HUMERAL REVERSE METAPHYSIS +9MM/0°

Model Number	04.01.0111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 march 2025: lot 2114023: (b)(4) items manufactured and released on 09-mar-2022.Expiration date: 2027-02-28.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.Additional components involved: batch review performed on 20 march 2025: reverse shoulder system 04.01.0123 humeral reverse hc liner ø39/+3mm (k170452) lot 2218469: (b)(4) items manufactured and released on 04-oct-2022.Expiration date: 2027-09-19.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.Reverse shoulder system 04.01.0208 lat.Glenosphere 39xø24.5 (k193175) lot 2243585: (b)(4) items manufactured and released on 16-dec-2022.Expiration date: 2027-11-30.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.Reverse shoulder system 04.01.0190 threaded glenoid baseplate ø24.5x25 (k171058) lot 2306948: (b)(4) items manufactured and released on 06-sep-2023.Expiration date: 2028-08-19.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.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, the patient came in reporting pain due to a dislocation of the liner from the glenosphere and the cause is unknown.The surgeon revised the metaphysis and liner.The surgery was completed successfully.On (b)(6) 2025, the patient came in reporting instability and the cause is unknown.The surgeon revised the glenosphere, metaphysis, and liner.Ther surgery was complete successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: HUMERAL REVERSE METAPHYSIS +9MM/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: 21771468
• Report Number: 3005180920-2025-00276
• Device Sequence Number: 20891938
• Product Code: PHX
• UDI-Device Identifier: 07630040706186
• UDI-Public: 07630040706186
• 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: 2024
• 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): 04/04/2025

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: 04.01.0111
• Device Lot Number: 2114023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2022
• 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: 71 YR
• Patient Sex: Male