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

Model Number	6195-1-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "patient was revised due to possible infection.No other information available due to hospital policy." right knee.A 3x13 ts insert was exchanged for another.

• 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: 19535036
• Report Number: 9615014-2024-00007
• Device Sequence Number: 8540647
• Product Code: MBB
• UDI-Device Identifier: 04260056885761
• UDI-Public: 04260056885761
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K123081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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: 06/30/2021
• Device Model Number: 6195-1-001
• Device Catalogue Number: 6195-1-010
• Device Lot Number: 926BA906AA
• 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: 05/22/2024
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2019
• 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 CEMENTED STEMREF 5560-S-112LOT 0086190M; TRI CEMENTED STEMREF 5560-S-112LOT 0100474M; TRI LM/RL TIB AUG REF 5545-A-301LOT ERFFP6D; TRI RM/LL TIB AUGREF 5545-A-302LOT ERFWN2D; TRI TS BASEPLATEREF 5521-B-300LOT DUO3EA; TRI TS FEMURREF 5512-F-302LOT DGZ7H; TRI X3 TS+ TIB INSERTREF 5537-G-313-ELOT WL0DLX; TRIATH FEM DISTAL AUG REF 5540-A-302LOT AUL3L; TRIATH FEM DISTAL AUGREF 5540-A-302LOT B749L; TRIATHLON CTR FEM CONE AUGREF 5549-A-642LOT KM4A; TRIATHLON SYM CONE AUGREF 5549-A-110LOT EJM4
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Female