MAUDE Adverse Event Report: OSARTIS GMBH SIMPLEX HV

Model Number 6194-1-001

Device Problem Device Handling Problem (3265)

Patient Problem Failure of Implant (1924)

Event Date 05/18/2021

Event Type  malfunction  

Event Description

Patient scheduled for a revision total knee arthroplasty (rtka).Surgeon reported intra-op that after the cement was mixed per manufacturer's recommendations, the cement was tacky when handled.Surgeon also reported the cement was setting up quicker at 8-9 minutes, earlier than manufacturer's guide.

• Brand Name: SIMPLEX HV
• Type of Device: SIMPLEX HV
• 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: 12075039
• MDR Text Key: 258645001
• Report Number: 9615014-2021-00007
• 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: foreign,health professional
• Reporter Occupation: Risk Manager
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 6194-1-001
• Device Catalogue Number: 6194-1-010
• Device Lot Number: 013AC844CB, 011AA828BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2020
• 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 Age: 57 YR
• Patient Weight: 106