MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27; SHOULDER GLENOSPHERE

Model Number	04.01.0173
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary surgery on the (b)(6) 2022.At about 10 months after the primary, from the x-rays has been noticed the unscrewing of the screw from the glenosphere.The surgeon do not plan to revise the implant at this time and continues with the follow-up observation.
Additional Manufacturer Narrative
Batch review performed on 19-apr-2023.Lot 2003974: (b)(4) items manufactured and released on 25-feb-2021.Expiration date: 2026-02-15.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medical affairs département: at about 10 months after the primary rsa surgery, from the x-rays has been noticed the unscrewing of the screw from the glenosphere.The causes for disassociation cannot be determined with certainty with the elements at hand.Normally, this happens if the taper spigot of the baseplate could not engage fully the glenosphere matching taper.Such an occurrence may be due to a baseplate screw head protruding from the baseplate surface, and preventing the glenosphere to reach its final seating.The surgeon does not plan to revise the implant at this time and continues with the follow-up observation.From the radiographic image it is visible that the baseplate and the glenosphere are not fully engaged therefore it may be possible that the stability of the baseplate connected with the glenosphere is compromised.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27
• Common Device Name: SHOULDER GLENOSPHERE
• 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: 16813415
• Report Number: 3005180920-2023-00305
• Device Sequence Number: 12195915
• Product Code: PHX
• UDI-Device Identifier: 07630040706605
• UDI-Public: 07630040706605
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 04/26/2023

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: 02/15/2026
• Device Model Number: 04.01.0173
• Device Catalogue Number: 04.01.0173
• Device Lot Number: 2003974
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2021
• 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: 80 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian