MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GRS BASEPLATE - Ø24.5X20 +6MM; SHOULDER REVERSE SYSTEM BASEPLATE

Catalog Number	04.01.0302
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Joint Dislocation (2374); Inadequate Osseointegration (2646)
Date of Event	04/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Primary surgery on (b)(6) 2023 after a tonic clonic seizure with posterior luxations on both the left and right shoulder on (b)(6) 2023.Bone grafts used.Revision surgery performed on (b)(6) 2024 after recurrent shoulder luxations on the right side and glenoid baseplate loosening.Change of baseplate, screws, glenosphere and liner.
Additional Manufacturer Narrative
Batch review performed on 7 june 2024 lot 2205361: (b)(4) items manufactured and released on 24-oct-2022.Expiration date: 2027-oct-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.Clinical evaluation performed by medical affairs department revision 1 year and 2 months after primary rsa, due to recurrent luxation and glenoid baseplate loosening.A bone graft was used and it may be possible that the graft was not osteointegrated and caused the loosening.There is no reason to suspect a malfunctioning device.Additional involved implants batch review performed on 7 june 2024 on reverse shoulder system 04.01.0169 glenosphere - ø36x24.5 (k170452) lot.2201462 lot 2201462: (b)(4) items manufactured and released on 25-may-2022.Expiration date: 2027-may-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 1 similar reported event during the period of review.Batch review performed on 7 june 2024 on reverse shoulder system 04.01.0119 humeral reverse hc liner ø36/+0mm (k170452) lot.2215133 lot 2215133: (b)(4) items manufactured and released on 18-oct-2022.Expiration date: 2027-oct-02.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.

• Brand Name: REVERSE SHOULDER SYSTEM GRS BASEPLATE - Ø24.5X20 +6MM
• Common Device Name: SHOULDER REVERSE SYSTEM BASEPLATE
• 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: 19603233
• Report Number: 3005180920-2024-00466
• Device Sequence Number: 7392406
• Product Code: PHX
• UDI-Device Identifier: 07630345710314
• UDI-Public: 07630345710314
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K213459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 06/25/2024

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 Catalogue Number: 04.01.0302
• Device Lot Number: 2205361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2022
• 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 Age: 58 YR
• Patient Sex: Female