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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ENDURO TIBIA HEMI-WEDGE T3 4MM RL/LM KNEE ENDOPROSTHESES

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AESCULAP AG ENDURO TIBIA HEMI-WEDGE T3 4MM RL/LM KNEE ENDOPROSTHESES Back to Search Results
Model Number NB075K
Device Problems Unsealed Device Packaging (1444); Shipping Damage or Problem (1570)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2021
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 nb075k - enduro tibia hemi-wedge t3 4mm rl/lm. According to the complaint description, both tibial wedges had been punctured by the sterile packaging and were therefore non-sterile. One of the wedges nb065k fell directly out of the sterile packaging onto the floor during handover. Nb075k had clearly leaked through the sterile packaging. An additional medical intervention was necessary. Additional information has been requested but not yet received as of this report. Additional patient information is not available. The adverse event is filed under aag reference (b)(4). Associated medwatch-reports: 9610612-2021-00480 ((b)(4)- nb065k).
 
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Brand NameENDURO TIBIA HEMI-WEDGE T3 4MM RL/LM
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 Key12102253
MDR Text Key266229372
Report Number9610612-2021-00479
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 09/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNB075K
Device Catalogue NumberNB075K
Device Lot Number52107302
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/12/2015
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/01/2021 Patient Sequence Number: 1
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