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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG E.MOTION PATELLA 3-PEGS P6 41X12MM KNEE ENDOPROSTHESES

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AESCULAP AG E.MOTION PATELLA 3-PEGS P6 41X12MM KNEE ENDOPROSTHESES Back to Search Results
Model Number NO486
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/17/2020
Event Type  malfunction  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report. (b)(4).
 
Event Description
It was reported that there was an issue with no486 - e. Motion patella 3-pegs p6 41x12mm. According to the complaint description, a expired prothesis was implanted. There was no described patient harm. Additional information was not provided nor available. The malfunction is filed under aag reference (b)(4).
 
Manufacturer Narrative
Based upon new information received, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.
 
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Brand NameE.MOTION PATELLA 3-PEGS P6 41X12MM
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
christian von der grün
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key11050353
MDR Text Key241253937
Report Number9610612-2020-00930
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeFR
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,Followup
Report Date 04/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Model NumberNO486
Device Catalogue NumberNO486
Device Lot Number52193521
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 Received03/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/20/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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