MAUDE Adverse Event Report: OSARTIS GMBH SIMPLEX HV; SIMPLEX HV WITH GENTAMICIN

Model Number	6195-1-001
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Arthralgia (2355); Joint Laxity (4526); Implant Pain (4561)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient information provided by the us distribution partner: "my knee never fully worked after the surgery and the implant became loose, my knee would bend all the way backwards , i've fallen a few times and so much pain.I also have to get knee replacement to replace the implant and currently wearing a brace.Did therapy at home and with therapist.Scheduled surgery in 2024 to replace the original implant." no information regarding the revision surgery has been provided.

• Brand Name: SIMPLEX HV
• Common Device Name: SIMPLEX HV WITH GENTAMICIN
• 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: 19612001
• Report Number: 9615014-2024-00008
• Device Sequence Number: 20576615
• Product Code: MBB
• UDI-Device Identifier: 04260056885761
• UDI-Public: 04260056885761
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K123081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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
• Device Expiration Date: 11/30/2023
• Device Model Number: 6195-1-001
• Device Catalogue Number: 6195-1-010
• Device Lot Number: 145BB909GC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2022
• 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: TRI TS BASEPLATEREF 5521-B-300LOT IDL9YB; TRIATHLON CR FEM COMPREF 5510F301LOT PNA3R; X3 TRIATHLON CS INSERTREF 5531-G-309-ELOT 11888R
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 90 KG