MAUDE Adverse Event Report: OSARTIS GMBH SIMPLEX; SIMPLEX HV

Model Number	6194-1-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) 2015: right medial mck uni knee exchange (b)(6) 2024: i&d on a right knee that had an mck uni on both the medial and lateral sides.(b)(6) 2024: revision of tibial insert, due to suspected infection.This report is due to the infection revised on (b)(6) 2024.

• Brand Name: SIMPLEX
• Common Device Name: SIMPLEX HV
• Manufacturer (Section D): OSARTIS GMBH; auf der beune 101; muenster, hesse 64839 ; GM 64839
• Manufacturer (Section G): OSARTIS GMBH; auf der beune 101; muenster, hesse 64839 ; GM 64839
• Manufacturer Contact: volker stirnal ; auf der beune 101; muenster, hesse 64839 ; GM 64839
• MDR Report Key: 20449176
• Report Number: 9615014-2024-00012
• Device Sequence Number: 15254832
• Product Code: LOD
• UDI-Device Identifier: 04260056885747
• UDI-Public: 04260056885747
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K123225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 10/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: 6194-1-001
• Device Catalogue Number: 6194-1-010
• Device Lot Number: 333AB922IE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MCK FEMORAL-LM-RL-SZ 3REF 180503LOT CPB4-1; MCK FEMORAL-RM-LL-SZ 3REF 180513LOT 26240615-01; MCK PATELLOFEMORAL-R-SZ 3REF 180413LOT A6LM-1; MCK TIB BASEPLATE-LM/RLREF 180603LOT 26031023-01; MCK TIB BASEPLATE-RM/LLREF 180614LOT 26480815-01; MCK TIB ONLAY INSERTREF 180704-1LOT 12120515-2; PALACOS R +GREF 00-1113-140-01LOT 82054447; TRITANIUM PATELLA-ASYMREF 5552-L-299LOT WJX31; X3 UNI ONLAY TIB INSERTREF 180733-1-ELOT 9R4KK0
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Female