MAUDE Adverse Event Report: OSARTIS GMBH SIMPLEX HV

Model Number	6494-1-001
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); Inadequate Osseointegration (2646); Joint Laxity (4526)
Date of Event	10/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient called the supplier to report that they had a procedure on (b)(6) 2023 with stryker implants on their left knee.They stated that they experienced loosening and some of the implant failed.

• Brand Name: SIMPLEX HV
• Common Device Name: SIMPLEX HV
• Manufacturer (Section D): OSARTIS GMBH; auf der beune 101; muenster, 46839 ; GM 46839
• Manufacturer (Section G): OSARTIS GMBH; auf der beune 101; muenster, 64839 ; GM 64839
• Manufacturer Contact: volker stirnal ; auf der beune 101; muenster, 64839 ; GM 64839
• MDR Report Key: 21090810
• Report Number: 9615014-2025-00001
• Device Sequence Number: 15739632
• Product Code: LOD
• UDI-Device Identifier: 04260056885747
• UDI-Public: 04260056885747
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 01/07/2025

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: 03/31/2024
• Device Model Number: 6494-1-001
• Device Catalogue Number: 6194-1-010
• Device Lot Number: 211AC962LC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2022
• 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: SIMPLEX HV.REF (B)(4).LOT 219AA823AD.; TRI CR FEM COMP.REF (B)(4).LOT RYE9S.; TRI PATELLA X3.REF (B)(4).LOT VEAR.; TRI TS BASEPLATE.REF (B)(4).LOT I7Z4HA.; TRI X3 CS INTSERT.REF (B)(4).LOT 74621W.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 190 KG