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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 ENDOPROSTHETICS

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AESCULAP AG ENDURO TIBIA HEMI-WEDGE T3 4MM RL/LM KNEE ENDOPROSTHETICS Back to Search Results
Model Number NB075K
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
Investigation on going. Additional information / results will be submitted in a supplemental report.
 
Event Description
It was reported that there was an issue with enduro tibia. According to the customer description, it was reported that the sterile packaging was faulty, so that when the unsterile nurse unpacked or handed the implant, it fell out of the packaging onto the floor. No identical implant was available. The 4mm tibial wedge is only available once per side. The height of the inlay was reduced by 4mm (14mm to 10mm) (inlay was not yet open) and the wedges were increased by 4mm (4mm to 8mm), which clinically leads to the same result and has no disadvantages for the patient during the treatment. An additional medical intervention was necessary. Additional information was not provided nor available / was not available. Additional patient information is not available. The adverse event / malfunction is filed under aag reference (b)(4).
 
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Brand NameENDURO TIBIA HEMI-WEDGE T3 4MM RL/LM
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 Key10564158
MDR Text Key208543069
Report Number9610612-2020-00509
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 11/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNB075K
Device Catalogue NumberNB075K
Device Lot Number52152406
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/25/2015
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: 09/21/2020 Patient Sequence Number: 1
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