MAUDE Adverse Event Report: SAINT JOSEPH´S HOSPITAL SIMPLEX HV

Model Number 6194-1-001

Device Problem Device Handling Problem (3265)

Patient Problem Failure of Implant (1924)

Event Date 05/11/2021

Event Type  malfunction  

Event Description

Patient scheduled for a left total knee artheroplasty (ltka), intraoperatively surgeon reported to the crew once the cement was mixed, cement was tacky and set up quicker than manufacturer's guide.Once the surgeon went to implant the patella, a concern was addressed in that the cement was hard to work with.At that time the or crew opened an additional unit of cement along with an additional mixing bowl.Case proceeded in a normal sterile fashion.

• Brand Name: SIMPLEX HV
• Type of Device: SIMPLEX HV
• Manufacturer (Section D): SAINT JOSEPH´S HOSPITAL; 3200 pleasant valley rd.; west bend WI 53095
• 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: 12074248
• MDR Text Key: 258631617
• Report Number: 9615014-2021-00006
• 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: 76 YR
• Patient Weight: 100