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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG AS ENDURO FEMORAL COMPONENT CEMENTED F1R PREVIOUSLY REPORTED

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AESCULAP AG AS ENDURO FEMORAL COMPONENT CEMENTED F1R PREVIOUSLY REPORTED Back to Search Results
Model Number NB017Z
Device Problems Unstable (1667); Contamination /Decontamination Problem (2895); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Pain (1994)
Event Date 03/06/2019
Event Type  Injury  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
 
Event Description
It was reported that there was an issue with as enduro components. The pre-operative diagnosis in 2017 was status post total knee replacement with multi-directional instability, associated with the lumen. The patient was initially implanted with enduro components on (b)(6) 2017. The type of cement used in the initial surgery was utilized with simplex and followed by stimulan pellets with 240mg of tobramycin and 500 mg of vancomycin per mixture; and components were comented one-on-one with tobramycin. There was a failed right total knee with hinge, revision due to loosening with some evidence of black carbon debris on (b)(6) 2019. The patient had been experiencing increased pain. A revision surgery was necessary. The implant that was revised was the aesculap enduro tibia and femur. All components were cemented one-on-one with tobramycin, followed by stimulan pellets and tobramycin and vancomycin mixture. Additional information was requested. The adverse event is filed under xc (b)(4). Associated medwatch-reports: ((b)(4)), 2916714-2020-00101 ((b)(4)).
 
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Brand NameAS ENDURO FEMORAL COMPONENT CEMENTED F1R
Type of DevicePREVIOUSLY REPORTED
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
MDR Report Key9933979
MDR Text Key187399443
Report Number2916714-2020-00082
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNB017Z
Device Catalogue NumberNB017Z
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/09/2020
Event Location Hospital
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/08/2020 Patient Sequence Number: 1
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