MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0190 THREADED GLENOID BASEPLATE 24.5X25; REVERSE SHOULDER GLENOID BASEPLATE

Model Number	04.01.0190
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: few days after primary rsa, the scapular baseplate detached from the bone.The report mentions the poor bone quality of the patient, which is a probable cause for the adverse event.The surgeon converted the rsa to tsa, cementing a pe glenoid to the scapula.No reason to suspect a faulty implant at the origin of this adverse event.Preliminary investigation performed by r&d manager: the x-rays confirm the mobilization of the threaded baseplate and subsequent cranialization of the humerus.A large bone residual is visible at the base of the threaded post.Frontal x-rays (if available) and a visual inspection of the explants are required to proceed with the investigation.Batch review performed on 08.07.2021: lot 1811892: (b)(4) items manufactured and released on 17-jul-2019.Expiration date: 2024-07-01.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.
Event or Problem Description
Revision surgery performed 1 month after the primary due to the baseplate pulling out of the bone(the patient had poor bone quality).The surgeon converted the patient from reverse to anatomic system.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0190 THREADED GLENOID BASEPLATE 24.5X25
• Common Device Name: REVERSE SHOULDER GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12266745
• Report Number: 3005180920-2021-00626
• Device Sequence Number: 17237338
• Product Code: PHX
• UDI-Device Identifier: 07630040708098
• UDI-Public: 07630040708098
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2021

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: 07/01/2024
• Device Model Number: 04.01.0190
• Device Catalogue Number: 04.01.0190
• Device Lot Number: 1811892
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 08/03/2021
• 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