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 05/12/2021

Event Type  malfunction  

Event Description

Stryker hv cement is used during total knee arthroplasty procedures (left total knee arthroplasty).Surgeon reported during case that this cement is chronically inconsistent in handling characteristics and working time.The stryker hy cement continues to be less sticky, rubbery, and does not adhere as well to the implants like cement that surgeon has utilized in the past.

• 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: 12075043
• MDR Text Key: 258723175
• Report Number: 9615014-2021-00008
• 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
• 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: 85 YR
• Patient Weight: 74