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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 Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Failure of Implant (1924); Implant Pain (4561)
Event Date 05/03/2021
Event Type  Injury  
Event Description
It was reported that there was an issue with an unspecified enduro product. The as enduro knee (right knee) was revised due to pain, swelling and loosening. The original implant date was on (b)(6) 2019 and revision on (b)(6) 2021. A revision surgery was necessary. Additional information was not provided. Additional patient information is not available. The adverse event is filed under xc reference (b)(4).
 
Manufacturer Narrative
If additional information / investigation results become available, they will be provided in a supplemental report.
 
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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 Key12924656
MDR Text Key281678378
Report Number2916714-2021-00226
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,Followup
Report Date 12/03/2021,01/26/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/03/2021
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 FDA12/03/2021
Distributor Facility Aware Date11/08/2021
Event Location Hospital
Date Report to Manufacturer11/08/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/03/2021 Patient Sequence Number: 1
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