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	Loss of Range of Motion (2032)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 months after primary, the patient came in reporting stiffness and limited mobility and the cause is unknown.The surgeon revised the glenosphere, liner and metaphysis.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 03-mar-2025: lot 2244281: (b)(4) items manufactured and released on 12-apr-2023.Expiration date: 22-mar-2028.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 implants involved, batch review performed on 03-mar-2025: reverse shoulder system 04.01.0119 humeral reverse hc liner ø36/+0mm (k170452) lot 2300859: (b)(4) items manufactured and released on 03-may-2023.Expiration date: 18-apr-2028.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0207 lat.Glenosphere 36xø24.5 (k193175) lot 2305687: (b)(4) items manufactured and released on 10-may-2023.Expiration date: 23-apr-2028.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.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.
Additional Manufacturer Narrative
Investigating on mdr 3005180920-2025-01200 (same patient of this complaint), on (b)(6) 2025, it was discovered that the patient age reported in the report is not correct.Patient date of birth is (b)(6) 1954.Additionally, the correct primary surgery date is (b)(6) 2023.
Event or Problem Description
At about 1 year and 6 months after primary, the patient came in reporting stiffness and limited mobility and the cause is unknown.The surgeon revised the glenosphere, liner and metaphysis.The surgery was completed 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: 21617414
• Report Number: 3005180920-2025-00195
• Device Sequence Number: 8510087
• 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: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: 2244281
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2023
• 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: 71 YR
• Patient Sex: Female
• Patient Race: White