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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG AS COLUMBUS CR NARROW FEMUR CEMENT.F6N R; KNEE ENDOPROSTHESES
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AESCULAP AG AS COLUMBUS CR NARROW FEMUR CEMENT.F6N R; KNEE ENDOPROSTHESES Back to Search Results
Model Number NN911Z
Device Problem Material Discolored (1170)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Manufacturing site evaluation: 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 as columbus cr narrow femur.According to the complaint description, the implant itself as well as the product label is discoloured and does not correspond to the standard.Discovery was not during goods receipt or in operation.There was no described patient harm.Another implant of the same size was available.Additional information was not provided nor available / was not 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 Name
AS COLUMBUS CR NARROW FEMUR CEMENT.F6N R
Type of Device
KNEE ENDOPROSTHESES
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM  78501
MDR Report Key11021166
MDR Text Key227797567
Report Number9610612-2020-00921
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberNN911Z
Device Catalogue NumberNN911Z
Device Lot Number52410660
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2020
Date Manufacturer Received01/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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