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

Catalog Number	04.01.0190
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 march 2024 lot 2300936: 43 items manufactured and released on 09-aug-2023.Expiration date: 2028-07-24.No anomalies found related to the problem.To date, 32 items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
At about 2 months after the primary, the patient came in reporting pain due to the malalignment of the threaded basesplate.There was a large inferior osteophyte in the native glenoid that was not removed, resulting in the glenoid implant placed too low.The surgeon revised the metaphysis, liner, glenosphere, and baseplate.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X25
• Common Device Name: SHOULDER GLENOID BASEPLATE REVERSE
• 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: 19040467
• Report Number: 3005180920-2024-00168
• Device Sequence Number: 8482970
• Product Code: PHX
• UDI-Device Identifier: 07630040708098
• UDI-Public: 07630040708098
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K171058
• 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): 04/04/2024

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 Catalogue Number: 04.01.0190
• Device Lot Number: 2300936
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2023
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Race: White