MAUDE Adverse Event Report: OSARTIS GMBH SIMPLEX HV WITH GENTAMICIN

Model Number 6195-1-001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 07/09/2018

Event Type  Injury  

Event Description

On (b)(6) 2016, (b)(6) underwent left-sided total knee replacement surgery performed by md (b)(6) at (b)(6) hospital in (b)(6).He was implanted with simplex hv with gentamicin bone cement and unknown knee components.On (b)(6) 2018, ms.(b)(6) underwent revision surgery due to mechanical loosening of her knee components in her left knee.This surgery was performed by md (b)(6) at (b)(6) medical center in (b)(6).The information regarding the revision surgery have been provided during filing of a lawsuit.No x-rays are available.No further information have been provided.

• Brand Name: SIMPLEX HV WITH GENTAMICIN
• Type of Device: SIMPLEX HV WITH GENTAMICIN
• Manufacturer (Section D): OSARTIS GMBH; auf der beune 101; muenster, 64839 ; GM 64839
• Manufacturer (Section G): OSARTIS GMBH; lagerstrasse 11-15; dieburg, 64807 ; GM 64807
• Manufacturer Contact: volker stirnal ; auf der beune 101; muenster, 64839 ; GM 64839
• MDR Report Key: 10533840
• MDR Text Key: 206968786
• Report Number: 9615014-2020-00012
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 04260056885761
• UDI-Public: 04260056885761
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6195-1-001
• Device Catalogue Number: 6195-1-001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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