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U.S. Department of Health and Human Services

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

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AESCULAP AG AS ENDURO TIBIA HEMI-WEDGE T3 4MM RL/LM KNEE ENDOPROSTHESES Back to Search Results
Model Number NB075Z
Device Problems Contamination (1120); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/03/2020
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 the packaging of an enduro tibia hemi-wedge. According to the complaint description the unstability of the implant was identified during surgery. There was no patient harm. Additional information was not provided. The malfunction is filed under aag reference (b)(4). Involved components: nb075z - as enduro tibia hemi-wedge t3 4mm rl/lm - batch 52041421.
 
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Brand NameAS ENDURO 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 Key10619954
MDR Text Key209603155
Report Number9610612-2020-00575
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 01/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNB075Z
Device Catalogue NumberNB075Z
Device Lot Number52041421
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/27/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/02/2020 Patient Sequence Number: 1
Treatment
NB075Z - BATCH 52041421
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