MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; REVERSE SHOULDER SYSTEM 04.01.0400 GRS BASEPLATE - Ø24.5X20 - FULL WEDGE 10°

Model Number	04.01.0400
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Preliminary evaluation performed by r&d project manager: as per provided information, a lateralized glenosphere was used in combination with a grs full wedge baseplate.As reported in the surgical technique, this coupling is not cleared as it leads to higher lever-arm and increased risk of implant loosening.This coupling in combination with the reported poor bone quality may have led to implant mobilization.Clinical evaluation performed by medical affairs department: revision surgery was performed 1.5 months after primary rsa due to a loose glenoid baseplate.Based on the images provided, the low quality of the images makes it impossible to assess the position of the baseplate.For the primary procedure, the grs full wedge 10-degree baseplate and the lateralized glenosphere were used.This coupling challenges the fixation of the implant to the bone, particularly in cases of poor bone quality.The choice must have been made by the surgeon based on anatomical and biomechanical considerations but it didn't resist the test of real life.Batch review performed on 30 december 2024.Reverse shoulder system 04.01.0400 grs baseplate - ø24.5x20 - full wedge 10° (k231911) lot 2315755: (b)(4) items manufactured and released on 22-apr-2024.Expiration date: 2029-apr-05.No anomalies found related to the problem.To date, 39 items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0158 glenoid polyaxial locking screw - l18 (k170452) lot 2411138: (b)(4) items manufactured and released on 21-jun-2024.Expiration date: 2029-jun-03.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 04.01.0159 glenoid polyaxial locking screw - l22 (k170452) lot 2405923: (b)(4) items manufactured and released on 29-apr-2024.Expiration date: 2029-apr-10.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 04.01.0161 glenoid polyaxial locking screw - l30 (k170452) lot 2409392: (b)(4) items manufactured and released on 27-may-2024.Expiration date: 2029-may-09.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 (two devices involved in the present case).As reported in the surgical technique, this coupling is not cleared as it leads to higher lever-arm and increased risk of implant loosening.This coupling in combination with the reported poor bone quality may have led to implant mobilization.
Event or Problem Description
The patient came in reporting pain due to a loose glenoid baseplate and the cause is unknown.About 1 month and a half after the primary surgery, the surgeon revised the baseplate, liner, metaphysis, glenosphere, and screws (metaphysis was removed to access the glenoid components).The surgery was completed successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: REVERSE SHOULDER SYSTEM 04.01.0400 GRS BASEPLATE - Ø24.5X20 - FULL WEDGE 10°
• 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: 21122215
• Report Number: 3005180920-2024-01168
• Device Sequence Number: 15319340
• Product Code: PHX
• UDI-Device Identifier: 07630542714627
• UDI-Public: 07630542714627
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K231911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 01/10/2025

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: 04.01.0400
• Device Lot Number: 2315755
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2024
• 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: Unknown