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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
 
Event Description
It was reported that a patient had a knee implant removed.The original implant date was not provided.The explanted knee was a univation x product.Further details on patient condition, medical devices, surgical information, test results, and dates have been requested but not yet provided.
 
Manufacturer Narrative
Investigation: no product is at hand.Conclusion and root cause: based on the information available, it is not possible to determine a possible root cause for the failure.Rationale: due to the fact that we did not receive any devices or further information for an investigation, it is not possible to determine a conclusion and root cause.No capa is necessary.
 
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Brand Name
COLLECT.NO.QAS KNEE IMPLANTS UNIVATION
Type of Device
KNEE ENDOPROSTHESES
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM  78501
MDR Report Key8108462
MDR Text Key128561233
Report Number9610612-2018-00521
Device Sequence Number1
Product Code HRY
Combination Product (y/n)N
PMA/PMN Number
K131167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberAE-QAS-K521-54
Device Catalogue NumberAE-QAS-K521-54
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date11/29/2018
Date Manufacturer Received11/01/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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