MAUDE Adverse Event Report: OSARTIS GMBH SIMPLEX HV WITH GENTAMICIN

Model Number	6195-1-001
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Arthralgia (2355)
Date of Event	11/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient's attorney through a legal claim that allegedly on (b)(6) 2016 the patient underwent a left knee medial compartment makoplasty and during that procedure simplex hv bone cement with gentamicin was utilized to cement all components.It is further alleged that on (b)(6) 2019 the patient underwent revision surgery due to loosening of her tibial component.No additional information have been provided.

• Brand Name: SIMPLEX HV WITH GENTAMICIN
• Common Device Name: SIMPLEX HV WITH GENTAMICIN
• Manufacturer (Section D): OSARTIS GMBH; auf der beune 101; muenster, hesse 64839 ; GM 64839
• MDR Report Key: 10815561
• Report Number: 9615014-2020-00028
• Device Sequence Number: 2113372
• Product Code: MBB
• UDI-Device Identifier: 04260056885761
• UDI-Public: 04260056885761
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K123081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 11/10/2020

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: 08/31/2017
• Device Model Number: 6195-1-001
• Device Catalogue Number: 6195-1-010
• Device Lot Number: 535BA914HW
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MCK FEMORAL-LM-RL-SZ 2LOT 233735K-1REF 180502; MCK TIBIAL BASEPLATELOT 26191115-01REF 180602; MCK TIBIAL ONLAY INSLOT 12390615-2REF 180702-1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR