MAUDE Adverse Event Report: OSARTIS GMBH SIMPLEX HV; 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)
Health Effect - Clinical Codes	Arthralgia (2355); Joint Laxity (4526); Implant Pain (4561)
Date of Event	12/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right knee was revised due to swelling, clanking, and joint laxity.A cr cemented femur and cs insert were revised to ps implants.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, heese 64839 ; GM 64839
• MDR Report Key: 16049971
• Report Number: 9615014-2022-00014
• Device Sequence Number: 6395249
• Product Code: MBB
• UDI-Device Identifier: 24260056885765
• 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: 2022
• Device Explanted Year: 2022
• 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): 12/27/2022

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: 05/31/2023
• Device Model Number: 6195-1-001
• Device Catalogue Number: 6195-1-010
• Device Lot Number: 121BB837BC
• 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: 12/06/2022
• Initial Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• 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 BASEPLATEREF 5521-B-600LOT G473AA; TRI CR FEM COMPREF 5510F602LOT N647T; TRI CS INS 9MMREF 5531G609LOT TW3XLN; TRI SYM PATELLAREF 5550G360ELOT HXPM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 88 KG