MAUDE Adverse Event Report: OSARTIS GMBH SIMPLEX HV US; SIMPLEX HV BONE CEMENT

Model Number	6194-1-001
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Problems during application of the bone cement, the cement has been removed and repeated with an additional unit.The problem has happened 2 times on the same day, the implantation has been finished with 15 minutes delay.

• Brand Name: SIMPLEX HV US
• Common Device Name: SIMPLEX HV BONE CEMENT
• Manufacturer (Section D): OSARTIS GMBH; auf der beune 101; muenster, hessen 46839 ; GM 46839
• Manufacturer (Section G): OSARTIS GMBH; auf der beune 101; muenster, 64839 ; GM 64839
• Manufacturer Contact: volker stirnal ; auf der beune 101; muenster, 64839 ; GM 64839
• MDR Report Key: 22008413
• Report Number: 9615014-2025-00004
• Device Sequence Number: 17441397
• Product Code: LOD
• UDI-Device Identifier: 04260056885747
• UDI-Public: 04260056885747
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K123225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 05/13/2025

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: 08/31/2026
• Device Model Number: 6194-1-001
• Device Catalogue Number: 6194-1-001
• Device Lot Number: 433AA977JF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2024
• 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: Other
• Patient Sex: Unknown