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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ENDURO TIBIAL COMP.OFFSET CEMENTED T1 KNEE ENDOPROSTHESES

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AESCULAP AG ENDURO TIBIAL COMP.OFFSET CEMENTED T1 KNEE ENDOPROSTHESES Back to Search Results
Model Number NB011K
Device Problems Delivered as Unsterile Product (1421); Expiration Date Error (2528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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 nb011k, enduro tibial comp. Offset cemented t1. According to the complaint description, the implant expired. According to the packaging, the implant has been expired since may 2021. There was no described patient harm. The fault was detected before usage. Additional information was not provided. The malfunction is filed under aag reference (b)(4).
 
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Brand NameENDURO TIBIAL COMP.OFFSET CEMENTED T1
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 Key12249423
MDR Text Key264276718
Report Number9610612-2021-00521
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 Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Model NumberNB011K
Device Catalogue NumberNB011K
Device Lot Number52249627
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/14/2016
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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