MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0152 GLENOID BASEPLATE Ø24.5X25; SHOULDER GLENOID BASEPLATE

Model Number 04.01.0152

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/03/2022

Event Type  Injury  

Event Description

At about 2 months after the primary surgery, revision surgery was performed due to a glenoid bone fracture.The cause of this bone fracture is not known.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 07-jun-2022.Lot 2110376: (b)(4) items manufactured and released on 22-nov-2021.Expiration date: 2026-nov-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported case during the period of review.Clinical evaluation performed by medical affairs manager: revision 2 months after primary rsa in a (b)(6) patient due to glenoid fracture.The reason of this event is unknown.No reason to suspect that this event is due to a faulty device.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0152 GLENOID BASEPLATE Ø24.5X25
• Type of Device: SHOULDER GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14883694
• MDR Text Key: 295110670
• Report Number: 3005180920-2022-00503
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706391
• UDI-Public: 07630040706391
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.01.0152
• Device Catalogue Number: 04.01.0152
• Device Lot Number: 2110376
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/22/2021
• 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
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White