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

Catalog Number 04.01.0190

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 03/05/2024

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 339335047
• Report Number: 3005180920-2024-00168
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040708098
• UDI-Public: 07630040708098
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 04.01.0190
• Device Lot Number: 2300936
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Race: White