MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GLENOID RECONSTRUCTION SYSTEM; GRS BASEPLATE - Ø24.5X30 +3MM

Model Number	04.01.0304
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, the patient underwent primary surgery with my shoulder planning and grs using a bone graft to correct glenoid retroversion.The construct was stable and the patient was doing well.During a follow-up visit, it was observed that the graft had resorbed, leading to glenoid loosening and the breakage of two polyaxial screws.On (b)(6) 2025, the implants were removed and replaced with a cement spacer to enable ct scan planning for a custom-made glenoid implant.
Additional Manufacturer Narrative
Batch review performed on 23 september 2025: reverse shoulder system 04.01.0304 grs baseplate 24.5x30+3mm (k213459) lot: 2219484: (b)(4) items manufactured and released on 27-april-2023.Expiration date: 04-april-2028.No anomalies found related to the problem.To date, (b)(4) items from the same lot have been sold, with no similar reported event during the review period.Additional implants involved, batch review performed on 23 september 2025: reverse shoulder system 04.01.0163 glenoid polyaxial locking screw - l38 (k170452) lot: 2240236: (b)(4) items manufactured and released on 22-nov-2022.Expiration date: 06-nov-2027.No anomalies found related to the problem.To date, (b)(4) items from the same lot have been sold, with no similar reported event during the review period.Reverse shoulder system 04.01.0163 glenoid polyaxial locking screw - l38 (k170452) lot: 179107a: (b)(4) items manufactured and released on 22-feb-2023.Expiration date: 29-jan-2028.No anomalies found related to the problem.To date, all items from the same lot have been sold, with no similar reported event during the review period.Conclusion: based on the information available no definitive root cause can be established for this case, while the current analysis has not identified a systemic deficiency or potential manufacturing related cause.

• Brand Name: GLENOID RECONSTRUCTION SYSTEM
• Common Device Name: GRS BASEPLATE - Ø24.5X30 +3MM
• 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: 23290524
• Report Number: 3005180920-2025-01013
• Device Sequence Number: 10107511
• Product Code: PHX
• UDI-Device Identifier: 07630345710338
• UDI-Public: 07630345710338
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K213459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 10/14/2025

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: 04.01.0304
• Device Lot Number: 2219484
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2023
• 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 Age: 71 YR
• Patient Sex: Male