MAUDE Adverse Event Report: OSARTIS GMBH 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	Hypersensitivity/Allergic reaction (1907); Arthralgia (2355)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient alleges allergic reaction and pending revision for both of his knee replacements.

• Brand Name: SIMPLEX HV
• Common Device Name: SIMPLEX HV
• Manufacturer (Section D): OSARTIS GMBH; auf der beune 101; muenster, hessen 64839 ; GM 64839
• Manufacturer (Section G): OSARTIS GMBH; auf der beune 101; muenster, hessen 64839 ; GM 64839
• Manufacturer Contact: volker stirnal ; auf der beune 101; muenster, hessen 64839 ; GM 64839
• MDR Report Key: 21932408
• Report Number: 9615014-2025-00003
• Device Sequence Number: 21088010
• Product Code: LOD
• UDI-Device Identifier: 04260056885747
• UDI-Public: 04260056885747
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K123225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 04/30/2025

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: 04/30/2022
• Device Model Number: 6194-1-001
• Device Catalogue Number: 6194-1-010
• Device Lot Number: 015AA885FB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STERILE HEADLESS 1/8 PIN X 3.5 INREF (B)(4); TRI ASYM X3 PATELLAREF (B)(4)LOT 6A5R; TRI CR FEM COMP #6 R-CEMREF (B)(4)LOT JD97L; TRI PRIM TIB BPL CEM SZ 6REF (B)(4)LOTG9V4YA; X3 TRI CS INS NO 6 9MMREF (B)(4)LOT T35JHK
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Male