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 Codes	Arthralgia (2355); Implant Pain (4561)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right knee was revised after patient complaint of pain following 2 falls.Prior to the falls the knee was great.Pre-operatively, surgeon reported tibial fracture and baseplate subsidence.The baseplate, insert, and femoral component were revised.The sales rep confirmed femur was revised to convert to a ps knee, and that there were no allegations against the revised insert.The patellar component was retained.The rep confirmed that no further information will be released by the hospital or surgeon.

• 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: 16944038
• Report Number: 9615014-2023-00007
• Device Sequence Number: 14000512
• Product Code: MBB
• UDI-Device Identifier: 04260056885761
• UDI-Public: 04260056885761
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 05/17/2023

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: 07/31/2019
• Device Model Number: 6195-1-001
• Device Catalogue Number: 6195-1-010
• Device Lot Number: 727BA870DY
• 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: 04/26/2023
• Initial Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2017
• 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 CR FEM COMP,REF 5510-F-402,LOT DPX3H.; TRI PRIM TIB BASEPL,REF 5520-B-300,LOT BLH4TB.; TRI TIBIAL INSERT CS,REF 5531-G-311,LOT LHL568.; TRI X3 PATELLA,REF 5550-G319,LOT N66T.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 83 KG