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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG COLLECT.NO.QAS KNEE IMPLANTS UNIVATION KNEE ENDOPROSTHESES
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AESCULAP AG COLLECT.NO.QAS KNEE IMPLANTS UNIVATION KNEE ENDOPROSTHESES Back to Search Results
Model Number AE-QAS-K521-54
Device Problem Mechanical Problem (1384)
Patient Problem Failure of Implant (1924)
Event Date 01/21/2021
Event Type  Injury  
Manufacturer Narrative
Manufacturing site evaluation: additional information / investigation results will be provided in a supplemental report, if available.
 
Event Description
It was reported that there was an issue with a unknown univation knee system. According to the complaint description, the device was revised post surgery. The plaintiff underwent knee replacement surgery on (b)(6) 2017 to replace the right knee and (b)(6) 2018 to replace the left knee. Subsequent revision surgery was performed on (b)(6) 2021 to replace the right knee. A revision surgery was necessary. Additional information was not provided nor available. Additional patient information is not available. The adverse event is filed under aag reference (b)(4).
 
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Brand NameCOLLECT.NO.QAS KNEE IMPLANTS UNIVATION
Type of DeviceKNEE ENDOPROSTHESES
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
MDR Report Key11813500
MDR Text Key252016168
Report Number2916714-2021-00072
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 05/12/2021,06/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAE-QAS-K521-54
Device Catalogue NumberAE-QAS-K521-54
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/12/2021
Distributor Facility Aware Date04/14/2021
Event Location Hospital
Date Report to Manufacturer04/14/2021
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: 05/12/2021 Patient Sequence Number: 1
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