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

Model Number 04.01.0190

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Date 08/12/2022

Event Type  Injury  

Event Description

Revision surgery performed 2 months after the primary due to threaded glenoid baseplate mobilization.The surgeon explanted the baseplate, screws, glenosphere, pe liner and humeral metaphysis.

Manufacturer Narrative

Batch review performed on 02-sep-2022.Lot 2113957: (b)(4) items manufactured and released on 09-feb-2022.Expiration date: 2027-01-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X25
• Type of Device: SHOULDER GLENOID BASEPLATE
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15368480
• MDR Text Key: 299358715
• Report Number: 3005180920-2022-00681
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/07/2022

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 Model Number: 04.01.0190
• Device Catalogue Number: 04.01.0190
• Device Lot Number: 2113957
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2022
• Initial Date FDA Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/09/2022
• 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 Sex: Male