MAUDE Adverse Event Report: OSARTIS GMBH SIMPLEX; SIMPLEX HV

Model Number	6194-1-001
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Arthralgia (2355); Implant Pain (4561)
Date of Event	04/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Daughter of patient reported that within a year of primary right knee surgery, (b)(6) 2019, her mother experienced implant "failure" and within two years required a revision, (b)(6), 2021.Patient experienced a femur fracture during the revision which required a "rod" to be placed.Patient currently experiences right knee stiffness and swelling.Patient did experience pain at/around her third post op visit which she reported to her surgeon at the time.Patient confirmed that she was actively doing physical therapy at the time of the onset of pain.Update 11/14/2023: per medical review addendum, the surgeon found malrotation of both femur and tibia contributing to the patient's symptoms, as well as most likely loosening of the femoral component based upon ease of removal.Update: 11/27/2023: per med review, the surgeon states there was notice of part of the cement mantle being broken off at approximately 3 months after the surgery.

• 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: 18343827
• Report Number: 9615014-2023-00017
• Device Sequence Number: 12151846
• Product Code: LOD
• UDI-Device Identifier: 04260056885747
• UDI-Public: 04260056885747
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K123225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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): 12/18/2023

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: 10/31/2020
• Device Model Number: 6194-1-001
• Device Catalogue Number: 6194-1-010
• Device Lot Number: 843AA924EZ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2019
• 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 PRIM TIB BASEPLATEREF (B)(4)LOT HD73T; TRI PS FEM COMPREF (B)(4)LOT AAS7YAAR7O; TRI SYM X3 PATELLAREF (B)(4)LOT 29HX; TRI X3 TIB INSERTREF (B)(4)LOT 9A1KLV
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 62 KG