MAUDE Adverse Event Report: OSARTIS GMBH SIMPLEX HV GENTA

Model Number 6195-1-001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Loss of Range of Motion (2032)

Event Date 04/19/2019

Event Type  Injury  

Event Description

It was reported a stage 1 revision was performed on patient's left knee.An irrigation and debridement was performed, all tka components were removed and an antibiotic spacer was placed.Rep provided the primary implant sheet and reported that no further information will be released by the hospital or surgeon.

• Brand Name: SIMPLEX HV GENTA
• Type of Device: SIMPLEX HV
• Manufacturer (Section D): OSARTIS GMBH; lagerstrasse 11-15; dieburg, 64807 ; GM 64807
• Manufacturer (Section G): OSARTIS GMBH; lagerstrasse 11-15; dieburg, 64807 ; GM 64807
• Manufacturer Contact: volker stirnal ; lagerstrasse 11-15; dieburg, 64807 ; GM 64807
• MDR Report Key: 8902575
• MDR Text Key: 154624307
• Report Number: 9615014-2019-00003
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 04260056885761
• UDI-Public: 04260056885761
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/15/2019

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
• Device Operator: No Information
• Device Expiration Date: 09/30/2020
• Device Model Number: 6195-1-001
• Device Catalogue Number: 6195-1-010
• Device Lot Number: 836BA920EZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NO 7. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 11MM; TRI TS BASEPLATE SIZE 7; TRIATHLON ASYMMETRIC X3 PATELLA; TRIATHLON PS FEM COMP #8L-CEM, LIM
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 122