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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG COLLECT.NO.QAS KNEE IMPL.MISC./UNKNOWN KNEE ENDOPROSTHESES

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AESCULAP AG COLLECT.NO.QAS KNEE IMPL.MISC./UNKNOWN KNEE ENDOPROSTHESES Back to Search Results
Model Number AE-QAS-K521-99
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Implant Pain (4561)
Event Date 01/06/2019
Event Type  Injury  
Manufacturer Narrative
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 the enduro knee system. Specifically, it was reported that as a result of having the product implanted the patient has experienced, knee pain, difficulties in walking and swelling, which resulted in a revision surgery. The primary surgery occurred on (b)(6) 2017, and the revision surgery occurred on (b)(6) 2019. Additional information was not available. The adverse event is filed under aag reference (b)(4).
 
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Brand NameCOLLECT.NO.QAS KNEE IMPL.MISC./UNKNOWN
Type of DeviceKNEE ENDOPROSTHESES
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
nadine schweikart
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key10240402
MDR Text Key197805733
Report Number9610612-2020-00255
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101815
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 10/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAE-QAS-K521-99
Device Catalogue NumberAE-QAS-K521-99
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 Received09/04/2020
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: 07/07/2020 Patient Sequence Number: 1
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