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

Model Number	04.01.0110
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Joint Laxity (4526); Metal Related Pathology (4530); Aseptic loosening (4883)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 dec 2025.Reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot.2403496: (b)(4) items manufactured and released on 01-jul-2024.Expiration date: 2029-jun-13.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 04.01.0302 grs baseplate - d 24.5x20 +6mm (k213459) lot.2308499: (b)(4) items manufactured and released on 13-dec-2023.Expiration date: 2028-nov-22.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 04.01.0170 glenosphere - d 39x24.5 (k170452) lot.2401263: (b)(4) items manufactured and released on 21-may-2024.Expiration date: 2029-may-02.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 04.01.0123 humeral reverse hc liner d 39/+3mm (k170452) lot.2402706: (b)(4) items manufactured and released on 21-may-2024.Expiration date: 2029-may-06.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.Clinical evaluation performed by clinical affairs department.Revision surgery was performed 1 year and 2 months after the previous procedure due to instability.This was the patient’s second revision, although the initial implants were not from medacta.During the revision, the glenosphere screw and the baseplate were found to be loose, and abundant metallosis debris was observed at the glenosphere/baseplate interface.As the explanted components have not been examined yet, it is not possible to determine the exact origin of these findings; however, they may be related to insufficient tightening of the screw, although the underlying cause leading to this condition cannot be definitively identified.Root cause: 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 primary right shoulder surgery using competitor products.On (b)(6) 2024, the patient was revised with medacta products.Presently, on (b)(6) 2025, the patient came in due to instability.The surgeon found ~40-50cc of gray fluid consistent with metallosis.The glenosphere screw was found to be loose, and abundant metallosis debris at the glenosphere/baseplate interface.The baseplate was found to be loose in the glenoid, and due to the cavity left behind from the baseplate post, the cavity was filled with cancellous bone chips and dbm putty.The surgeon converted the patient to a hemiarthroplasty with plans for the patient to return for a revision.
Additional Manufacturer Narrative
Investigation performed by r&d project manager: the presence of metallosis and the provided description suggest relative movement between the glenosphere and the baseplate, in addition to the described baseplate mobilization.The x-ray shows radiolucent lines behind the baseplate backsurface and around the central post, which is in line with the described baseplate mobilization.The provided pictures do not show any particular unexpected sign.Given the information at hand, it is not possible to determine the root cause of the event.No action is suggested.Additional information: - h11 investigation performed by r&d project manager.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: HUMERAL REVERSE METAPHYSIS +0MM/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: 23858474
• Report Number: 3005180920-2025-01288
• Device Sequence Number: 10374650
• Product Code: PHX
• UDI-Device Identifier: 07630040706179
• UDI-Public: 07630040706179
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: 04.01.0110
• Device Lot Number: 2403496
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2024
• 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: Male
• Patient Race: White