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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG AS TIBIA OFFSET STEM D12X52MM CEMENTED KNEE ENDOPROSTHETICS

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AESCULAP AG AS TIBIA OFFSET STEM D12X52MM CEMENTED KNEE ENDOPROSTHETICS Back to Search Results
Model Number NR191Z
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem Pain (1994)
Event Date 03/23/2020
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 patient was initially implanted with enduro components on (b)(6) 2019. All components were cemented one-on-one with tobramycin placement of stimulan pellets with 240mg of tobramycin follow by 100mg of vancomycin per mixture. The pre-operative diagnosis in 2020 was multi-directional instability following the primary left total knee. There later was a failed left total knee and revision on (b)(6) 2020, and there had been increased pain noted prior to surgery. During the procedure, black debris was found from the carbon fiber slip. A revision surgery was necessary. The implants that were revised were the aesculap enduro components. A competitor's products were used instead. Additional information was requested. The adverse event is filed under xc (b)(4). Associated medwatches: 2916714-2020-00083, 2916714-2020-00100, 2916714-2020-00097, 2916714-2020-00091, 2916714-2020-00093.
 
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Brand NameAS TIBIA OFFSET STEM D12X52MM CEMENTED
Type of DeviceKNEE ENDOPROSTHETICS
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
MDR Report Key9940489
MDR Text Key187397399
Report Number2916714-2020-00090
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 07/02/2020
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 NumberNR191Z
Device Catalogue NumberNR191Z
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/15/2020
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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