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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 Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2021
Event Type  Injury  
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 when unpacking the nr 867k implant, it was discovered that the foil was not 100% sealed. Another implant had to be taken, nevertheless no significant surgery time delay. An additional medical intervention was necessary. A different size was used and therefore had to be prepared differently. Additional patient information is not available. The adverse event / malfunction is filed under aag reference (b)(4).
 
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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 Key13047835
MDR Text Key283694729
Report Number9610612-2021-00778
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 User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNR867K
Device Catalogue NumberNR867K
Device Lot Number52335513
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/31/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/09/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/20/2021 Patient Sequence Number: 1
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