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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSARTIS GMBH SIMPLEX HV GENTA

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OSARTIS GMBH SIMPLEX HV GENTA Back to Search Results
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.

 
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Brand NameSIMPLEX HV GENTA
Type of DeviceSIMPLEX 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 Key8902575
MDR Text Key154624307
Report Number9615014-2019-00003
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK123081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,DISTRIBUTOR,FOREIGN
Reporter Occupation
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
Date FDA Received08/16/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device EXPIRATION Date09/30/2020
Device MODEL Number6195-1-001
Device Catalogue Number6195-1-010
Device LOT Number836BA920EZ
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/14/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/16/2019 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
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