MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; GRS BASEPLATE - Ø24.5X20 - FULL WEDGE 10°

Model Number	04.01.0400
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	02/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 febr 2026.Reverse shoulder system 04.01.0400 grs baseplate - d 24.5x20 - full wedge 10° (k231911) lot 2339030: (b)(4) items manufactured and released on 04-sept-2024.Expiration date: 2029-aug-05.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 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot.2433334: (b)(4) items manufactured and released on 15-may-2025.Expiration date: 2030-apr-22.No anomalies 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.Reverse shoulder system 04.01.0121 humeral reverse hc liner d 36/+6mm (k170452) lot.2246172: (b)(4) items manufactured and released on 03-may-2023.Expiration date: 2028-apr-18.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 04.01.0169 glenosphere - d 36x24.5 (k170452) lot.2430413: (b)(4) items manufactured and released on 10-mar-2023.Expiration date: 2030-feb-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.Root cause: 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
The patient had primary right shoulder on (b)(6) 2019 with an anatomical shoulder system.On (b)(6) 2025, the patient came in reporting pain due to a failed rotator cuff and the cause is unknown.The surgeon converted the patient from an anatomic shoulder to reverse shoulder.The surgery was completed successfully.Presently, on (b)(6) 2026, the patient came in due to signs of infection and the pathogen is unknown.The surgeon removed all medacta implants and implanted antibiotic spacers.The surgery was completed successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: GRS BASEPLATE - Ø24.5X20 - FULL WEDGE 10°
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 24454902
• Report Number: 3005180920-2026-00131
• Device Sequence Number: 18634173
• Product Code: PHX
• UDI-Device Identifier: 07630542714627
• UDI-Public: 07630542714627
• Combination Product (Y/N): N
• PMA/510(K) Number: K231911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2026

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: 04.01.0400
• Device Lot Number: 2339030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2024
• 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