MAUDE Adverse Event Report: OSARTIS GMBH SIMPLEX; SIMPLEX HV

Model Number	6194-1-001
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Arthralgia (2355); Implant Pain (4561)
Date of Event	03/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Dr.(b)(6) revised a left medial uni originally done on (b)(6) 2023 due to persistent pain.No allegations were made against the implants.Dr.Has revised to a primary triathlon with universal baseplate.

• 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: 19199819
• Report Number: 9615014-2024-00004
• Device Sequence Number: 7952244
• 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: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 04/29/2024

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: 05/31/2024
• Device Model Number: 6194-1-001
• Device Catalogue Number: 6194-1-010
• Device Lot Number: 219AB824AD
• 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: 04/03/2024
• Initial Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2022
• 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: MAKO X3 ONLAY INSERT REF 180736-1-ELOT T87VRJ; MCK FEMORAL-LM-RL-SZ 6REF 180506LOT 2GV1-1; MCK TIB BASEPLATEREF 180606LOT 26360821-01
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Sex: Male