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

Catalog Number	04.01.0152
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 december 2019: lot 175032: (b)(4) items manufactured and released on 08-nov-2017.Expiration date: 2022-10-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director 1 year after primary rsa, the position of the glenoid is changed in order to improve rom and reduce tendency to eterotopic ossification.This re-operation is due to surgeon's decision and not to a defective device.
Event or Problem Description
About 1 year and 2 months after primary the surgeon revised the patient shoulder.He recognized a baseplate mal positioning, it was too high, it impinged and created ossification.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø24.5X25
• Common Device Name: REVERSE SHOULDER GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9573859
• Report Number: 3005180920-2019-01130
• Device Sequence Number: 11479581
• Product Code: PHX
• UDI-Device Identifier: 07630040706391
• UDI-Public: 07630040706391
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2020

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: 10/25/2022
• Device Catalogue Number: 04.01.0152
• Device Lot Number: 175032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 01/10/2020
• 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 Age: 54 YR