MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; GLENOID BASEPLATE - Ø27X25

Model Number	04.01.0155
Medical Device Problem Codes	Fracture (1260); Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery case at about 1 year and 3 months post primary.The glenoid component was mobilized.The baseplate, screws and glenosphere altogether were detached from the glenoid, but assembled to each other.One of the 2 screws (unknown with of the 2 reported) was broken.Some metallosis was detected on the surface of the glenoid.The glenoid components were removed and the reverse metaphysis and humeral pe liner were removed as well.A safety endoprosthesis was implanted with an anatomical metaphysis (142), double eccenter and humeral head.The primary was performed with a bone graft for glenoid lateralization.The issue is due to a failure of the bone graft leading to anomalous screw loading and baseplate mobilization.
Additional Manufacturer Narrative
Batch review performed on 18 july 2025: lot 2201537: (b)(4) items manufactured and released on 22-may-2022.Expiration date: 2027-05-11.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.Additional components involved: batch review performed on 18 july 2025: reverse shoulder system 04.01.0200 glenoid polyaxial non-locking screw - l38 (k181826) lot 2246465: (b)(4) items manufactured and released on 30-jan-2023.Expiration date: 2028-01-12.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 04.01.0199 glenoid polyaxial non-locking screw - l34 (k181826) lot 2247067: (b)(4) items manufactured and released on 25-jan-2023.Expiration date: 2028-mar-01.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: the screw breakage is most likely the result of unintended excessive loading, which typically occurs due to a traumatic event or insufficient osseointegration of the bone graft.In this case, the failure of the bone graft healing and osseointegration seems to be the primary factor in the glenoid baseplate loosening and subsequent screw breakage.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: GLENOID BASEPLATE - Ø27X25
• 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: 22630833
• Report Number: 3005180920-2025-00715
• Device Sequence Number: 7994825
• Product Code: PHX
• UDI-Device Identifier: 07630040706421
• UDI-Public: 07630040706421
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2025

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 Model Number: 04.01.0155
• Device Lot Number: 2201537
• 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: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2022
• 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