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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSARTIS GMBH SIMPLEX HV WITH GENTAMICIN
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OSARTIS GMBH SIMPLEX HV WITH GENTAMICIN Back to Search Results
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 12/14/2020
Type of Reportable Event Serious Injury
Event or Problem Description
Revision of a right knee on (b)(6) 2020.The original implant date of ts surgery was on (b)(6) 2017.Reason for revision is infection.No more information is available per doctor.
 
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Brand Name
SIMPLEX HV WITH GENTAMICIN
Common Device Name
SIMPLEX HV WITH GENTAMICIN
Manufacturer (Section D)
OSARTIS GMBH
auf der beune 101
muenster 64839
MDR Report Key11160744
Report Number9615014-2020-00037
Device Sequence Number3526677
Product Code MBB
UDI-Device Identifier04260056885761
UDI-Public04260056885761
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K123081
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Physician
Remedial Action Notification
Type of Report Initial
Report Date (Section B) 01/13/2021
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 Date01/31/2019
Device Model Number6195-1-001
Device Catalogue Number6195-1-010
Device Lot Number702BB824AY
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/15/2020
Initial Report FDA Received Date01/13/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
TRI CEMENTED STEMREF: 5560-S-112LOT: 0055980A; TRI CEMENTED STEMREF: 5560-S-212LOT: 0044801J; TRI POST AUGMENTREF: 5543-A-500LOT: WIE3; TRI TS BASEPLATEREF: 5521-B-500LOT: AO33AA; TRIATHLON CR FEM COMPREF: 5510F502LOT: AAS9B; TRIATHLON FEM CONEREF: 5549-A-352LOT: A62E; TRIATHLON SYM CONEREF: 5549-A-120LOT: AMM7; TRIATHLON TS PLUS TIBIREF: 5537-G-513LOT: 424J28
Outcome Attributed to Adverse Event Other;
Patient Age66 YR
Patient Weight64
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