MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 11

Model Number	04.01.0184
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 august 2025 anatomical shoulder system 04.01.0184 short humeral diaphysis - cementless - 11 (k180089) lot.1906554: 12 items manufactured and released on 11 sept 2019.Expiration date: 28 august 2024.No anomalies were found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Additional devices also revised: anatomical shoulder system 04.01.0039 humeral anatomical metaphysis - cementless - 128° - 11 (k170910) lot.1710050: 80 items manufactured and released on 24 may 2018.Expiration date: 13 may 2023.No anomalies were found related to the problem.To date, 17 items of the same lot have been sold with no similar reported event during the period of review.Anatomical shoulder system 04.01.0089 double eccenter (k170910) lot.1905791: 108 items manufactured and released on 22 oct 2019.Expiration date: 07 oct 2024.No anomalies were found related to the problem.To date, 105 items of the same lot have been sold with no similar reported event during the period of review.Anatomical shoulder system 04.01.0093 metal humeral head ø46 (k170910) lot.1908187: 52 items manufactured and released on 12 feb 2020.Expiration date: 02 feb 2020.No anomalies were found related to the problem.To date, 49 items of the same lot have been sold with no similar reported event during the period of review.Anatomical shoulder system 04.01.0131 hc pegged glenoid ø46 (k170910) lot.184443: 53 items manufactured and released on 12 feb 2020.Expiration date: 27 jan 2024.No anomalies were found related to the problem.To date, 42 items of the same lot have been sold with no similar reported event during the period of review.Conclusions: 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
After 4 years and 11 years, the patient came in due to signs of an infection, and the pathogen is unknown.The surgeon performed a washout, removed all implants, and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 11
• 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: 22911272
• Report Number: 3005180920-2025-00815
• Device Sequence Number: 21128234
• Product Code: KWS
• UDI-Device Identifier: 07630040715928
• UDI-Public: 07630040715928
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

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: 08/28/2024
• Device Model Number: 04.01.0184
• Device Lot Number: 1906554
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2019
• 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: Female
• Patient Weight: 82 KG
• Patient Race: White