MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMIC SHOULDER PROSTHESIS; REVERSE SHOULDER SYSTEM STANDARD HUMERAL DIAPHYSIS - CEMENTLESS - 9

Model Number	04.01.0004
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	03/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 march 2025.Lot 2217103: (b)(4) items manufactured and released on 20-sep-2022.Expiration date: 2027-09-01.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.Additional implants revised.Batch review performed on 18 march 2025 on reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot.2313417.Lot 2313417: (b)(4) items manufactured and released on 27-sep-2023.Expiration date: 2028-sep-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 1 similar reported event during the period of review.Batch review performed on 18 march 2025 on reverse shoulder system 04.01.0119 humeral reverse hc liner ø36/+0mm (k170452) lot.2306772.Lot 2306772: (b)(4) items manufactured and released on 31-jul-2023.Expiration date: 2028-jul-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.Batch review performed on 18 march 2025 on reverse shoulder system 04.01.0190 threaded glenoid baseplate ø24.5x25 (k171058) lot.2300936.Lot 2300936: (b)(4) items manufactured and released on 09-aug-2023.Expiration date: 2028-07-24.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.Batch review performed on 18 march 2025 on reverse shoulder system 04.01.0207 lat.Glenosphere 36xø24.5 (k193175) lot.2309372.Lot 2309372: (b)(4) items manufactured and released on 01-jun-2023.Expiration date: 2028-05-14.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.Infection is a known possible complication of any surgery.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.
Event or Problem Description
Revision surgery at about 1 year and 4 months post primary the pathogen is unknown.The surgeon removed all medacta hardware and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: ANATOMIC SHOULDER PROSTHESIS
• Common Device Name: REVERSE SHOULDER SYSTEM STANDARD HUMERAL DIAPHYSIS - CEMENTLESS - 9
• 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: 21771299
• Report Number: 3005180920-2025-00269
• Device Sequence Number: 15992884
• Product Code: KWS
• UDI-Device Identifier: 07630040706032
• UDI-Public: 07630040706032
• 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: 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: 04.01.0004
• Device Lot Number: 2217103
• 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: 09/20/2022
• 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 Sex: Unknown