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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE KNEE ENDOPROSTHETICS

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AESCULAP AG COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE KNEE ENDOPROSTHETICS Back to Search Results
Model Number AE-QAS-K521-55
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
If additional information or investigation results become available, it will be provided in a supplemental report.
 
Event Description
It was reported that there was an issue with an enduro knee. According to the complaint description, there was a revision of an enduro knee system due to infection. The surgeon replaced it with another enduro implant. A revision surgery was necessary. Further details were not provided. The adverse event / malfunction is filed under (b)(4).
 
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Brand NameCOLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE
Type of DeviceKNEE ENDOPROSTHETICS
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
MDR Report Key10839789
MDR Text Key217665786
Report Number2916714-2020-00665
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 11/13/2020,09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAE-QAS-K521-55
Device Catalogue NumberAE-QAS-K521-55
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/13/2020
Distributor Facility Aware Date10/22/2020
Event Location Hospital
Date Report to Manufacturer10/22/2020
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: 11/13/2020 Patient Sequence Number: 1
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