MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GLENOID RECONSTRUCTION SYSTEM; REVERSE SHOULDER SYSTEM GRS BASEPLATE - Ø24.5X20

Model Number	04.01.0300
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Shoulder revision surgery on the right side performed on the (b)(6) 2024.Loosening of the glenoid components (bone of insufficient quality for a good hold of the grs baseplate despite the grab and the 4 screws.) primary surgery performed on the (b)(6) 2021.1st revision surgery performed on the (b)(6) 2024 for infection.Explantation of all primary components.Reimplantation of new reverse shoulder components + bone graft and with a long humeral stem.2nd revision surgery performed on the (b)(6) 2024 for luxation of glenosphere from baseplate.Explantation of the long humeral stem with the metaphysis and the liner, explantation of the glenosphere (to test the stability of the baseplate and the graft).Reimplantation of a new long humeral stem (cemented) with a new metaphysis and liner +6mm (155 degrees) and implantation of a new glenosphere (lateralized).3rd revision surgery performed (b)(6) 2024 for grs baseplate loosensing.Explantation of all components except the long humeral stem.Waiting for a new planning for a glenoid custom implant.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2024: 40 items manufactured and released on 27-jan-2022.Expiration date: 2027-01-10.No anomalies found related to the problem.To date, 27 items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs manager: revision 5 months after previous revision in a rsa due to loosening of the glenoid components.From the poor-quality image, the glenosphere appears dislocated.According to report, the bone is of insufficient quality for a good hold of the grs baseplate despite the grab and the 4 screws.This is also visible from the radiographic image.Since this is the 3rd revision performed (first infection, then loosening of the long humeral stem), the next step is to define a glenoid custom implant in order to develop an implant which stick to the weak bone.This is a very difficult case.Since the insufficient bone quality of the glenoid there is no reason to suspect a faulty device.Root cause: there is no indication that any potential issue with the device may have caused or contributed to the event, and the investigation does not indicate any potential manufacturing related issue.

• Brand Name: GLENOID RECONSTRUCTION SYSTEM
• Common Device Name: REVERSE SHOULDER SYSTEM GRS BASEPLATE - Ø24.5X20
• 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: 20746067
• Report Number: 3005180920-2024-00964
• Device Sequence Number: 15642285
• Product Code: PHX
• UDI-Device Identifier: 07630345710291
• UDI-Public: 07630345710291
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K213459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 11/21/2024

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 Model Number: 04.01.0300
• Device Lot Number: 2106799
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male