MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L18

Model Number	04.01.0158
Medical Device Problem Codes	Fracture (1260); Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about two months from primary rsa surgery with bone graft, the patient reported to emergency room for pain to the shoulder.During xrays, the abduction of the shoulder caused severe pain but implant seemed ok.Ten (10) days after the xrays, patient returned to emergency room again for pain and the xrays showed displaced implants and broken screw.According to the information received from the surgeon, it is likely that the bone graft failed to heal and caused the implant to fail.Currently, it is not known if the patient underwent a revision surgery or if a revision surgery is scheduled beacuse the patient was referred to different, unknown, center, and the surgeon and the sales representative do not have further information.
Additional Manufacturer Narrative
Batch review performed on 21-07-2025: reverse shoulder system 04.01.0158 glenoid polyaxial locking screw - l18 (k170452) lot 2410402: (b)(4) items manufactured and released on 14-06-2024 expiration date: 2029-06-02.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.It should be noted that two devices from this lot are involved in this event along with a third one from a different lot and it is not possible to confirm which one is the broken one.Reverse shoulder system 04.01.0155 glenoid baseplate - ø27x25 (k170452) lot 2416392: (b)(4) items manufactured and released on 20-09-2024 expiration date: 2029-09-04.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 04.01.0162 glenoid polyaxial locking screw - l34 (k170452) lot 2428979: (b)(4) items manufactured and released on 11-12-2024 expiration date: 2029-11-18.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.Clinical evaluation performed by clinical affairs department: two months after undergoing primary reverse shoulder arthroplasty (rsa) with bone grafting, the patient presented to the emergency department with shoulder pain during abduction.Ten days later, the patient returned, and x-rays revealed a broken screw and a displaced baseplate.According to the report, it is likely that the bone graft failed to integrate properly, leading to implant failure.Alternatively, an impingement may have occurred, resulting in screw breakage and subsequent displacement of the entire implant.At present, it is unknown whether the patient has undergone revision surgery or if one is scheduled, as the patient has since transferred to a different hospital.There is no indication that the implant components were defective.Root cause: although the root cause cannot be confirmed, the screw breakage is most likely the result of unintended excessive loading caused by insufficient osseointegration of the bone graft.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.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L18
• 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: 22564637
• Report Number: 3005180920-2025-00713
• Device Sequence Number: 9237864
• Product Code: PHX
• UDI-Device Identifier: 07630040706452
• UDI-Public: 07630040706452
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 07/22/2025

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: 04.01.0158
• Device Lot Number: 2410402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2024
• 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: Other; Required Intervention
• Patient Sex: Unknown