MAUDE Adverse Event Report: OSARTIS GMBH SIMPLEX HV; SIMPLEX HV GENTA

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	10/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left knee was revised due to infection (originally implanted on (b)(6) 2018).All implants, a 6x9 mm cr insert, size 5 cr femoral component, size 6 primary baseplate, and 39 mm symmetric patella were removed.A washout was done and a 6x13 mm ps insert, size 5 ps femoral component, size 6 universal baseplate, and new 39 mm patella were implanted.Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: SIMPLEX HV
• Common Device Name: SIMPLEX HV GENTA
• Manufacturer (Section D): OSARTIS GMBH; auf der beune 101; muenster, hesse 64839 ; GM 64839
• Manufacturer (Section G): OSARTIS GMBH; lagerstrasse 11-15; dieburg, hesse 64807 ; GM 64807
• Manufacturer Contact: volker stirnal ; auf der beune 101; muenster, hesse 64839 ; GM 64839
• MDR Report Key: 12801705
• Report Number: 9615014-2021-00017
• Device Sequence Number: 4778455
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 11/12/2021

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: 07/31/2020
• Device Model Number: 6195-1-001
• Device Catalogue Number: 6195-1-010
• Device Lot Number: 829BA840BZ
• 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: 10/20/2021
• Initial Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2018
• 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: TRIATHLO CR TIBIAL INSERT,REF 5530-G-60,LOT P93AVY.; TRIATHLON X3 PATELLA,REF 5550-G-391,LOT 966V.; TRIATHLON CR FEM COMP,REF 5510F501,LOT DXB9N.; TRIATHLON PRIM TIB BASEPL,REF5520-B-600,LOT AVA7XB.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Male