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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG AS ENDURO FEMORAL COMPONENT CEMENTED F1L PREVIOUSLY SUBMITTED

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AESCULAP AG AS ENDURO FEMORAL COMPONENT CEMENTED F1L PREVIOUSLY SUBMITTED Back to Search Results
Model Number NB014Z
Device Problems Fracture (1260); Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Clarification: on 19mar2020 additional information was received and 2 complaints were created for the patient, referencing the left knee arthroplasties. ((b)(4)). Associated medwatch-reports: right knee arthroplasties: 9610612-2019-00912 ((b)(4) nb018z), 9610612-2019-00913 ((b)(4) nr865z), 9610612-2019-00914 ((b)(4) nr295z), 9610612-2019-00916 ((b)(4) nr400z), 9610612-2019-00915 ((b)(4) nr882z), 9610612-2019-00917 ((b)(4) nb012z), 9610612-2019-01011 ((b)(4) nr192z).
 
Event Description
It was reported that there was an issue with enduro components. On (b)(6) 2014 the patient underwent a left total knee revision replacement; enduro implants were used and palacos cement. It was noted that a non-aesculap device was removed at that time. On (b)(6) 2015, the patient had left total knee arthroplasty (tka) for distal femoral peri-prosthetic fracture with loosening. The implants were replaced with enduro devices. Components were cemented one-on-one with tobramycin. On (b)(6) 2019, there was tibial and femoral loosening which required revision. A niobium-coated implant was used instead. Black staining of the tissues was noted. Additional treatments included stimulan pellets and vancomycin. Additional information has been requested. Associated medwatches: ((b)(4)), ((b)(4)). The patient has also undergone multiple right knee revisions.
 
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Brand NameAS ENDURO FEMORAL COMPONENT CEMENTED F1L
Type of DevicePREVIOUSLY SUBMITTED
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
MDR Report Key9935750
MDR Text Key187421451
Report Number2916714-2020-00094
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,Followup
Report Date 05/04/2020
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 NumberNB014Z
Device Catalogue NumberNB014Z
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/15/2020
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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