MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID BASEPLATE 24.5X25; REVERSE SHOULDER BASEPLATE

Model Number	04.01.0152
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06-nov-2020: lot 1904753: 80 items manufactured and released on 18-dec-2019.Expiration date: 08-dec-2024.No anomalies found related to the problem.To date, 51 items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs director: during implantation of rsa in a (b)(6) patient, a fracture was created on the glenoid bone and sufficient stability could not be achieved.Cement was used and the surgery terminated, but soon afterwards the glenoid component fell off the bone and revision was necessary.This problem was not caused by a device deficiency.
Event or Problem Description
(b)(6) patient operated with reverse shoulder system on (b)(6) 2020.Intra-operatively, the glenoid construct was unstable, the glenoid bone fractured and the baseplate mobilized completely.The fracture and the baseplate were cemented in order to fix the issue.After 3 days, the baseplate mobilized again, the patient was then revised.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE 24.5X25
• Common Device Name: REVERSE SHOULDER BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10904260
• Report Number: 3005180920-2020-00824
• Device Sequence Number: 19510322
• Product Code: PHX
• UDI-Device Identifier: 07630040706391
• UDI-Public: 07630040706391
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 11/25/2020

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 Expiration Date: 12/08/2024
• Device Model Number: 04.01.0152
• Device Catalogue Number: 04.01.0152
• Device Lot Number: 1904753
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 70