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

Model Number 6194-1-001

Device Problem Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2021

Event Type  malfunction  

Event Description

Dr.Was doing a total knee arthroplasty case.He initially used 2 batches of simplex hv cement.Both batches of cement had the same lot number.The surgical tech mixed the cement for 30 seconds (manufacturers recommendation) and the cement set up too quickly.Dr.Then ended up having to use an additional batch of simplex speedset cement to finish the case.No more information have been currently provided by the user facility or the responsible sales rep.

• Brand Name: SIMPLEX HV
• Type of Device: SIMPLEX HV BONE CEMENT
• Manufacturer (Section D): OSARTIS GMBH; auf der beune 101; muenster, hesse 64839 ; GM 64839
• Manufacturer (Section G): OSARTIS GMBH; lagerstrasse 11-15; dieburg, hesse 64807 ; GM 64807
• Manufacturer Contact: volker stirnal ; auf der beune 101; muenster, hesse 64839 ; GM 64839
• MDR Report Key: 12842471
• MDR Text Key: 281032540
• Report Number: 9615014-2021-00018
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 04260056885747
• UDI-Public: 04260056885747
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 6194-1-001
• Device Catalogue Number: 6194-1-010
• Device Lot Number: 038AA897HB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• 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): Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 98 KG