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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ENDURO FEMUR SPACER DISTAL F3 4MM KNEE ENDOPROSTHETICS

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AESCULAP AG ENDURO FEMUR SPACER DISTAL F3 4MM KNEE ENDOPROSTHETICS Back to Search Results
Model Number NR867K
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/07/2021
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 nr867k-enduro femur spacer distal f3 4mm. According to the complaint description, it was reported that during surgery that both nr867k with the lot numbers 52190399 and 52431771 were not sterile packed. The packaging was broken through. There was no described patient harm. The adverse event / malfunction is filed under aag reference (b)(4). Associated medwatch-reports: 9610612-2021-00647 (400528194 nr867k). 9610612-2021-00648 (400528195 nr867k).
 
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Brand NameENDURO FEMUR SPACER DISTAL F3 4MM
Type of DeviceKNEE ENDOPROSTHETICS
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 Key12555086
MDR Text Key274053298
Report Number9610612-2021-00648
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K101815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNR867K
Device Catalogue NumberNR867K
Device Lot Number52431771
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/17/2018
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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