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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG AS ENDURO FEMORAL COMPONENT CEMENTED F1R PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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AESCULAP AG AS ENDURO FEMORAL COMPONENT CEMENTED F1R PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number NB017Z
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Ambulation Difficulties (2544); Implant Pain (4561)
Event Type  Injury  
Manufacturer Narrative
Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis. Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event. An investigation of the device manufacturing records was not able to be conducted by the manufacturer as lot # of the device in question was not known. However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
Event Description
It was reported to aesculap inc. That a vega knee implant system was implanted during a primary surgery of the left knee performed on (b)(6) 2014. According to the complainant, following the primary surgery, the patient experienced knee pain, difficulty walking, as well as loosening and instability of the implant. There was no reported revision surgery. The complaint device was not available to be returned to the manufacturer for evaluation. Additional information has been requested, but has not been made available. The adverse event / malfunction is filed under aag reference (b)(4).
 
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Brand NameAS ENDURO FEMORAL COMPONENT CEMENTED F1R
Type of DevicePROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
MDR Report Key11739618
MDR Text Key247786652
Report Number2916714-2020-00636
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
Type of Report Initial
Report Date 04/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2021
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? Yes
Date Report Sent to FDA04/28/2021
Distributor Facility Aware Date04/02/2019
Event Location Hospital
Date Report to Manufacturer04/02/2019
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: 04/28/2021 Patient Sequence Number: 1
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