MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø24.5X15; SHOULDER REVERSE GLENOID BASEPLATE

Model Number 04.01.0151

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/09/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 30-may-2023 lot 2244719: 50 items manufactured and released on 05-apr-2023.Expiration date: 2028-03-16.No anomalies found related to the problem.To date, 25 items of the same lot have been sold without any similar reported event during the period of review.Additional involved implant: batch review performed on 30-may-2023 on reverse shoulder system 04.01.0169 glenosphere 36xø24.5 (k170452) lot.2247038 lot 2247038: 100 items manufactured and released on 17-feb-2023.Expiration date: 2028-01-31.No anomalies found related to the problem.To date, 25 items of the same lot have been sold without any similar reported event during the period of review.

Event Description

The glenoid bone fractured during the glenosphere thightening.Rsa implants were immediately revised with an hsa.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø24.5X15
• Type of Device: SHOULDER REVERSE GLENOID 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: 17077623
• MDR Text Key: 316669972
• Report Number: 3005180920-2023-00415
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706384
• UDI-Public: 07630040706384
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K170452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.01.0151
• Device Catalogue Number: 04.01.0151
• Device Lot Number: 2244719
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention