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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 Problems Biocompatibility (2886); Patient Device Interaction Problem (4001)
Patient Problems Unspecified Infection (1930); Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
Investigation on going. Additional information / results 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. The adverse event / malfunction is filed under aag reference (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
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
christian von der grün
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key10839738
MDR Text Key216330504
Report Number9610612-2020-00793
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 Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 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?
Event Location No Information
Date Manufacturer Received09/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/13/2020 Patient Sequence Number: 1
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